Candidate Key Competencies:

General

• Possess a positive attitude and optimistic outlook.
• Motivated and organized critical thinker with solid interpersonal and business communication skills.
• Demonstrated ability to work effectively within a team to set goals, develop sound project plans, monitor progress, and report results scientifically.
• Routinely communicate findings and information to other team members; transparency and knowledge sharing are expected and practiced.
• Advanced understanding of cGMP compliance in the biotech/bioprocessing manufacturing environment.
• Relevant pharma or biotech industry experience.
• Previous team management or leadership required.
• Exhibit and radiate energy and are comfortable in a player-coach role, with a strong commitment to growing 35 North into North Carolina’s premier Life Sciences Consulting Firm.

Specific

• Experience with design and operation of commercial pharmaceutical, cell culture, PCR/NGS Labs, or life sciences processes.
• Demonstrated understanding or leadership in a broad spectrum and experience in mentoring staff.
• Experienced leader with experience in program management, project management, project controls, construction management, commissioning, and qualification services in cGMP environments.
• Demonstrated history of working with design, construction, and engineering firms.
• Demonstrated experience with cGMP requirements for the life cycle facilities design, construction, maintenance, production, and documentation requirements associated with a cGMP environment.
• Detailed understanding of design and construction contract methodologies.
• Deep understanding of construction project life cycle:
  • Preconstruction
  • Bidding strategies
  • Buyout
  • Staffing
  • Budget/cost mgt
  • Schedule mgt
  • Quality mgt
  • Safety

Key Responsibilities:

The Director of Operations is responsible for the operation and performance of the Project Management and Commissioning & Operational Readiness teams at 35 North. The position is accountable for achieving business objectives that ensure quality delivery of services to our clients, and consistent growth in all business units. These responsibilities include, but are not limited to:

• Manage people and teams, responsible for all employees in the Project Management and Commissioning teams.
• Meet with all direct/indirect reports regularly to build relationships, coach employees, sense the pulse of the company, track goals and objectives, and develop connections.
• Train and mentor employees in areas of project management, project controls, and commissioning.
• Resolve performance concerns and policy disagreements with employees.
• Work together with project managers and commissioning engineers to make sure there is an efficient allocation of existing resources.
• Work together with BD and recruitment to make sure we have the necessary resources for all current and future projects.
• Assist in the development and maintenance of a business culture, which supports the company’s overall business objectives and goals, by providing leadership in issues that involve “cost, quality, process, schedule and people”.
• Develop, organize, and participate in 35 North’s cultural events.
• Take ownership of team voluntary turnover.
• Develop processes and procedures for the Project Management and Commissioning teams (Operational Excellence).
• Develop, implement, and own a comprehensive business strategy for the service units, including staffing plans, supporting policies and procedures, and training programs.
• Responsible for implementation of best practices for services, including operational excellence programs and metrics needed to achieve world-class services.
• Direct the activities of project management, project controls, and commissioning personnel.
• Oversee all project activities for clients. This includes ensuring quality of deliveries and efficient utilization of resources.
• Provide effective high-level oversight for the success of all company projects.
• Oversight of various projects simultaneously or intermittently as the case may be.
• Ensure work is allocated to project managers and commissioning managers in an appropriate manner and is prioritized based on urgency and customer needs.
• Develop, manage, and track departmental operating budgets.
• Work in some active projects and be billable.
• Capable of explaining technical information to clients or customers when the need arises.
• Meet resource utilization and project profitability goals by assessing and analyzing operational and financial risks that may be encountered in the execution of planned projects.
• Ensure every project is completed and delivered to the owner on schedule and budget.
• Manage overruns and change orders with clients.
• Assist in the maintenance, development, and enhancement of the company’s relationship with architects, engineers, consultants, and contractors – produce strategic partnerships.
• Ensure project challenges are quickly addressed, and coach project managers, cost estimators, and commissioning engineers.
• Link project managers, commissioning engineers, and the Leadership Team.
• As a seller-doer model, it is expected that the Director of Operations nourish relationships with existing clients and obtain additional work/projects.
• Work with Marketing and Business Development teams to deliver winning service proposals.
• Responsible for mapping out the sequence in which projects will be completed, the cost of such projects, and developing proposals in a timely manner.
• Responsible for project compliance with federal, state, and local regulatory authorities including FDA, EMA, OSHA, EPA, etc
• Develop, implement, staff, and own a safety program for the company compliant with federal, state, and local regulations.
• Ensure company’s commitment to maintaining a safe workplace and protecting the environment through the establishment of company policies and procedures.
• Ensure effective, timely communication both written and verbal to internal teams and external customers, contractors, and agencies.

Qualifications:

• Process Knowledge
  • Advanced understanding of contamination control topics including cleanroom operation, maintenance, HEPA filtration, disinfection, gowning, and proper material/personnel flow.
  • Advanced knowledge of pharmaceutical industry guidelines such as ISPE Baseline Guides, ISO, and ASME BPE.
  • Possess a firm understanding of equipment and procedures and identify potential problems before they occur.
  • Advanced understanding of facilities and utilities utilized in pharmaceutical manufacturing environments.
• Problem-Solving:
  • Critical thinker.
  • Able to develop and implement preventative action plans for non-obvious problems and confidently deal with corrective actions.
  • Act as a potential downstream resource for process development and participate in long-term strategic process development as needed.
• Communication:
  • Effectively communicate downstream, manufacturing process engineering concepts to both executive and scientific leadership.
  • Strong oral and written communication skills. Capable of writing management-level reports and summaries. Clearly communicate scientific and process issues with co-workers and supervisors and communicate in a timely manner.
• Budget and financials
  • Effectively manage operating budgets and effectively and regularly communicate status to the management team.

Minimum Qualifications:

• Extensive industry experience, 15+ years preferred.
• Minimum Bachelor’s Degree in Engineering (e.g., Mechanical, Chemical, Electrical, or Industrial), PE License preferred.
• Substantial experience with cGMP facility design, build, qualification, and maintenance.
• Experience with large capital projects.
• Direct experience with regulatory, OSHA, EPA, etc. inspections.
• Highly motivated and organized.
• Work and lead well in a team environment.

Compensation Target

Compensation range depends upon candidate qualifications and experience.

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Primary Responsibilities:

• Manage accounts payable – sets up new vendors in system, enters vendor invoices daily, manages and records vendor auto-pays, pulls monthly credit card statements for expense reporting, works with vendors to resolve billing issues, and prepares weekly ACH payment runs. Manage any changes to vendor names and/or bank accounts thru independent verification.
• Manage client billing – prepares client invoices during the monthly billing cycle working closely with Directors and Project Managers regarding billing details.
• Manage accounts receivable – works with Directors and Project Managers to keep A/R aging as current as possible and to track and resolve any aging AR.
• Record cash receipts.
• Process weekly timesheets and monthly expense reports.
• Complete monthly bank and payroll reconciliations.
• Maintain Excel-based balance sheet account roll-forwards.
• Create and maintain reports and dashboards.
• Enters and manages a variety of other data sets, including rate tables, billing terms and employee records in the ERP system.
• Perform ad-hoc analyses, administrative tasks, and special projects as required.
• Responds quickly and attentively to the requests of the Directors and Project Managers related to contracts, billing, and reporting.

Qualifications:

• Bachelor’s degree in accounting or related field, or equivalent experience.
• 3-5 years of accounting experience required, preferably in the AEC industry.
• Deltek Vantagepoint or Vision experience required.
• Must possess strong familiarity with finance/accounting activities including AP, Billing, AR.
• Strong user of Microsoft Office suite with at least intermediate-level skills in Excel.
• Comprehension of project cost accounting.
• High degree of accuracy and attention to detail.
• Excellent interpersonal and communication skills, displaying professionalism when assisting others.

Why 35 North? We make the complex simple.

We pride ourselves in offering a flexible, nimble workplace. We are a growing company with many opportunities for you to make an impact. 35 North offers a competitive benefits package that includes 401k, profit sharing, employer paid life insurance and long-term disability, full medical, dental, and vision benefits, and paid time-off and holidays.

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In the senior cost manager role, you’ll work closely with both our clients and our team members. You will be responsible for managing the delivering of quality solutions to our clients which include conceptual estimates, detailed cost estimates, constructability reviews, reconciliations, and more, as well as assist in the maintenance of client relationships. This will require the ability to manage, lead and mentor junior team members in aid of the development and delivery of projects. The successful candidate will be a self-starter with a passion for precision and customer service.

We are looking for positive and skilled individuals who are excited to be part of a dynamic and growing team.

Here are some responsibilities:

• Perform cost estimates, from conceptual design to detailed construction level documentation
• Ensure client satisfaction with cost management performance
• Lead project estimate process from kickoff through completion
• Lead project risk and pricing analysis
• Lead estimate development for: indirect costs, escalation/risk contingencies/forecasting, executive summaries, reconciliation, benchmarking, risk analysis, constructability reviews
• Source material and equipment quotes
• Assist in establishing scope of work and task hours on a project level
• Lead individual and group training on a project level
• Act as a mentor and assist in the development of team members

Qualifications:

• 5+ years of construction estimating experience
• Degree in Civil/Electrical/Mechanical Engineering, Construction Management, Quantity Surveying or similar preferred; a combination of education and work experience will also be considered
• Proficiency in On-Screen Takeoff (or similar take-off software), Bluebeam, Excel, and other Microsoft related software, CostX preferred
• Be a critical-thinker, self-starter, and creative problem solver

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Primary Responsibilities:

• Management of all project team members.
• Management of all project phases including planning, preconstruction, construction, project closeout and works closely with our commissioning team as needed.
• Prepare the detailed scopes of work for all subcontractors and purchase orders (including all schedule requirements and any other obligation required by the subcontractor or vendor), issue the formal agreements. Ensure all staff is familiar with subcontractor work scopes.
• Thorough review and understanding of the Owner’s contract to ensure compliance with all contractual requirements.
• Establishes the overall project’s procedures and execution plan.
• Develops the overall detailed project schedule. Ensures that schedule is incorporated into appropriate subcontracts and purchase orders. Monitor critical path activities frequently to document and if necessary, intervene to keep project on or ahead of schedule. Expedite material deliveries according to project schedule requirements. Identify potential schedule impacts including scope, weather, manpower changes, and facilitates mitigation plans for these impacts.
• Create staging, logistics, and phasing plan for project.
• Responsible for project startup, including obtaining permits and licenses, and managing jobsite mobilization.
• Establishes the project document control system to ensure the project is using the most current contract documents for construction. This includes the system to initiate and monitor Request for Information (RFIs) as well as the shop drawing control and management.
• All aspects of cost and profitability management. This includes change orders, internal cost coding, profitability analysis, and all other logs, reports, and tools to review, evaluate and manage cost expenditures.
• Prepare monthly status reports and progress reports.
• Lead responsibility for project quality control plan implementation and compliance.
• Provides appropriate written documentation for decisions affecting various aspects of the project such as budget, schedule, quality, and safety. Employs current best practices for documentation requirements.
• Prioritize, review, and expedite submittals.
• Attend OAC progress meetings and create monthly status reports.
• Manage and oversee job close-out documentation and procedures.

Required Qualifications:

• Bachelor’s degree in construction, engineering, or related field.
• Minimum of 5 years’ construction experience.
• Conflict resolution skills and experience with successfully resolving disputes.

Preferred but not Required Qualifications:

• Experience working on regulated industries and knowledge of regulatory and compliance requirements: FDA regulations, Good Engineering Practices (GEP), current Good Manufacturing Practices (cGMP), and Good Documentation Practices (GDP).
• Previous project experience in one or more of the following technologies and platforms: manufacturing and utilities systems; clean and aseptic rooms; clean-in-place (CIP); steam-in-place (SIP); autoclaves; vapor hydrogen peroxide (VHP) sterilization; solid dose preparation areas; powder feeding and continuous manufacturing; blending, milling, granulation, and formulation; fermentation, purification, and conjugation processes,; controlled temperature environments; injectables sterile fill and packaging facilities; conveyors and clean packaging automation; GMP warehousing; and, automated storage and retrieval warehouse systems.

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Primary Responsibilities:

• Assists in the preparation the detailed scopes of work for all subcontractors and purchase orders.
• Coordinates with project QA/QC planning and helps ensure project quality control plan implementation and compliance.
• Works with the project manager and subcontractors to prepare the overall detailed project schedule.
• Pre-plans crew activities, fulfills the requirements of the daily task plan, completes look-ahead schedule, and provides updates.
• Creates procurement logs based on the project schedule and specification requirements. Tracks shop drawings and follows up with the deliveries as directed by the project team.
• Works onsite with the project team to carry out a variety of tasks such as monitoring crew size, materials, and equipment.
• Prioritizes, reviews, and expedites submittals.
• Coordinates and inspects work and prepares a variety of reports including project daily reports, weekly progress reports, unit reporting, percentage complete, daily manpower, production schedules, equipment tracking, etc.
• Participates in activities such as punch lists, city inspections, safety reviews, quality reviews, and prepares the necessary documentation.
• Coordinates owner furnished items with project scope of work.
• Attends OAC progress meetings and assists in the creation of monthly status reports.

Required Qualifications:

• Engineering, construction, technical, or life sciences degrees preferred.
• Critical thinking – Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems.
• Complex problem solving – Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.
• Active listening – Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
• Speaking – Talking to others to convey information effectively.
• Coordination – Adjusting actions in relation to others’ actions.

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Primary Responsibilities:

• Assists in developing, implementing, maintaining, and enforcing a project site specific safety program.
• Coordinates and manages the care, custody, and control of the project site.
• Assists with the overall project schedule. Develops draft schedules, logistics plans, and manpower charts during the preconstruction process. Communicates schedule requirements to all project team members. Monitors schedule and in collaboration with project management.
• Prepares short-term “look-ahead” schedules. Records historical data for future use related to schedule and logistics.
• Participates in subcontractor scheduling, coordination, safety and project meetings, and documentation.
• Participates in various meetings including daily standup and weekly trade meetings.
• Actively participates in the procurement or “buyout” process. Reviews all purchase orders and subcontracts to ensure complete scope coverage prior to distribution.
• Maintains and enforces a quality workmanship program with all subcontractors. Implements and maintains the project’s Quality Control Program.
• Assists in the evaluation of project progress.
• Assists in the management of the building inspection process.
• Assists in ensuring the project budget is adhered to.

Required Qualifications:

• Bachelor’s degree in construction, engineering, or related field.
• Construction experience.
• Familiarity with construction and project management software.
• Excellent oral and written communication skills and interpersonal skills.

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Primary Qualifications:

• Lead and mentor a team of less experienced commissioning engineers to complete the commissioning and operational readiness of one or more projects
• Generate documents such as commissioning master plans, design qualification, equipment, facility and utility commissioning protocols, and final reports
• Perform commissioning and qualification testing on utilities and manufacturing process equipment and instruments
• Provide document control strategies in support of projects
• Provide project planning, management, and execution as needed
• Execute project management activities to ensure projects are on time, within scope, and within budget
• Manage multiple projects and resources simultaneously
• Provide design qualification services by reviewing engineering drawings for accuracy and act to correct any errors
• Review and assess systems; develop and review design specifications and engineering drawings to determine if systems meet project intent
• Review equipment specifications, user manuals, and engineering documentation to understand systems operation; test equipment and systems to assure they meet project requirements
• Investigate any deviations; manage client Corrective and Preventative Actions (CAPAs) and provide data analysis and summary reports
• Develop and review spare parts lists; ensures spare parts are adequate and cost effective; and setup spare part rooms operations for clients
• Create preventive maintenance strategies and maintenance job plans
• Perform system walk-downs and testing, identify gaps and non-conformances; analyze options and solutions; and make technical changes to systems
• Participate in professional organizations such as ISPE, PDA, ASQ, NCEES, NCBELS, AERGC or other professional organizations relevant to their area of expertise
• Becomes a “Subject Matter Expert” (SME) in his/her area of expertise, and share knowledge through presentations, training sessions, or meetings
• Develop and manage quality control, document control, and communication plans
• Provide constructability and document reviews during project execution
• Manage project change control to ensure project remains compliant
• Provide project commissioning updates on a consistent basis to various stakeholders
• Work collaboratively and build effective relationships with Client’s project team, owners and final users, design team, contractors, and local jurisdictional personnel
• Maintain a positive attitude in a fast-paced environment

Required Qualifications:

• Professional Engineering (PE) license desired
• Engineering, Technical or Life Science degrees preferred
• 5-10 years of experience in project and commissioning
• Experience with working on regulated industries and knowledge of regulatory and compliance requirements: FDA regulations, USDA Regulations, Good Engineering Practices (GEP), current Good Manufacturing Practices (cGMP), and Good Documentation Practices (GDP)
• Proficient with technical writing of documents such as: commissioning master plans (CMP): user requirements specifications (URS), risk assessments (RA), design qualification (DQ): factory acceptance tests (FAT), site acceptance tests (SAT), pre-functional tests (PFT), functional tests (FT), commissioning test plans (CTP), integrated system tests (IST), maintenance, calibration and spare parts assessments and plans: standard operating procedures (SOP) and guidelines
• Familiar with the Code of Federal Regulations (CFR) as related to cGMP in Manufacturing, Processing, Packaging, and Holding of Drugs and Finished Pharmaceuticals; Dietary Supplement & Human Food; Biological Products & General Biological Products Standards, Good Clinical Practices for Medical Devices, and Quality Systems regulations
• Previous project experience in one or more of the following technologies and platforms: manufacturing and utilities systems, clean and aseptic rooms, clean in place (CIP), steam in place (SIP), autoclaves, vapor hydrogen peroxide (VHP) sterilization, solid dose preparation areas, powder feeding and continuous manufacturing, blending, milling, granulation, and formulation, fermentation, purification, and conjugation processes, controlled temperature environments, injectables sterile fill and packaging facilities, conveyors and clean packaging automation, GMP warehousing, and/or automated storage and retrieval warehouse systems
• Successful experience interacting with clients to identify project needs and work towards solutions that meet schedule, cost, and quality expectations and requirements
• Organizational skills, oral & written communication, and team attitude
• Strong interpersonal skills and extremely resourceful in managing stakeholders
• Experience working in a corporate setting as a member of a project team or working independently with minimal supervision, if needed
• Strong understanding of mechanical, electrical, and automation systems: ability to read, interpret, and correct P&IDs, and experience with working in construction environments
• Detail-oriented with the ability to compile, analyze, summarize, and present data in a concise manner
• Excellent analytical skills and proven ability to solve problems creatively
• Strong familiarity with project management software tools, methodologies, and best practices
• Experience with seeing projects from conceptual design through operations
• Proven ability to complete projects according to outlined scope, budget, and timeline
• Proficient with computerized systems, information technology, and information systems related to project and construction software packages

Compensation will be determined based on education, years of commissioning experience, and alignment within the Life Science industry.

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Primary Qualifications:

• Generates documents such as commissioning master plans, design qualification, equipment, facility and utility commissioning protocols, and final reports.
• Performs commissioning and qualification testing on utilities and manufacturing process equipment and instruments
• Provides document control strategies in support of projects
• Provides project planning, management, and execution as needed
• Supports project management activities to ensure projects are on time, within scope and within budget
• Provides design qualification services by reviewing engineering drawings for accuracy and acts to correct any errors
• Reviews and assesses systems. Develops and reviews design specifications and engineering drawings to determine if systems meet project intent
• Reviews equipment specifications, user manuals, and engineering documentation to understand systems operation; tests equipment and systems to assure they meet project requirements
• Investigates any deviations, manages client Corrective and Preventative Actions (CAPAs), provides data analysis and summary reports
• Develops and reviews spare parts lists, ensures spare parts are adequate and cost effective, and setups spare part rooms operations for clients.
• Creates preventive maintenance strategies and maintenance job plans
• Performs system walk-downs and testing, identify gaps and non-conformances, analyses options and solutions, and makes technical changes to systems
• Develops and manage quality control, document control, and communication plans
• Provides constructability and document reviews during project execution
• Manages project change control to ensure project remains compliant
• Provides project commissioning updates on a consistent basis to various stakeholders
• Works collaboratively and build effective relationships with Client’s project team, owners and final users, design team, contractors, and local jurisdictional personnel
• Maintains a positive attitude in a fast-paced environment

Required Qualifications:

• Engineering, Technical or Life Science degrees preferred
• Less than 5 years of experience as project manager
• Organizational skills, oral & written communication, and team attitude
• Familiar with technical writing of documents such as: commissioning master plans (CMP), user requirements specifications (URS), risk assessments (RA), design qualification (DQ), factory acceptance tests (FAT), site acceptance tests (SAT), pre-functional tests (PFT), functional tests (FT), commissioning test plans (CTP), integrated system tests (IST), maintenance, calibration and spare parts assessments and plans, standard operating procedures (SOP), procedures and guidelines.
• Understanding of mechanical, electrical, and automation systems, ability to read, interpret and correct P&IDs, and experience working in construction environments.
• Detail oriented with the ability to compile, analyze, summarize, and present data in a concise manner
• Analytical skills and proven ability to solve problems creatively
• Familiarity with project management software tools, methodologies, and best practices
• Familiarity with regulated industries and knowledge of regulatory and compliance requirements: FDA regulations, USDA Regulations, Good Engineering Practices (GEP), current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
• Familiarity with the Code of Federal Regulations (CFR) as related to cGMP in Manufacturing, Processing, Packaging, and Holding of Drugs and Finished Pharmaceuticals; Dietary Supplement & Human Food; Biological Products & General Biological Products Standards; Good Clinical Practices for Medical devices; and, Quality Systems regulations.
• Proficient with computerized systems, information technology and information systems related to project and construction software packages

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