Sr. Program Manager
COMPANY DESCRIPTION
Syner-G BioPharma Group and Sequoia Biotech Consulting recently merged in September 2024, uniting two industry leaders to create a new force in life sciences consulting. By combining our expertise in product development, regulatory strategy, quality and compliance and commercial manufacturing, we are positioned to deliver fully integrated solutions across the development continuum.
We are helping to enhance human health. This merger strengthens our ability to accelerate groundbreaking therapies and help clients navigate the complex life sciences landscape with greater agility and confidence. Together, we form a leading life sciences consultancy dedicated to empowering organizations to overcome complex challenges and accelerate the speed to market, scale and quality of life-saving innovations.
We work across a diverse range of clients and projects, supporting many organizations through the most critical phases of the drug discovery, approval, product development, technology transfer and commercial manufacturing process. We also equip our partners with the tools, knowledge and expertise to streamline operations, enhance quality and ensure compliance.
Syner-G BioPharma Group was recently honored with BioSpace's prestigious "Best Places to Work" 2025 award, for the second consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.
At Syner-G and Sequoia, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.
For more information, visit www.Sequoiabiotech.com/ or www.Synergbiopharma.com
POSITION OVERVIEW:
We are seeking a Project Manager/Construction Manager (PMCM) to provide Owner’s Project Management Representation for the Clinical Label Expansion Project. The PMCM will support construction, equipment installation, commissioning (IQ/OQ/PQ Validation), and start-up. This role involves overseeing the strategic alignment and execution of the project, ensuring a smooth transition across all phases.
KEY RESPONSIBILITIES:
(This list is not exhaustive and may be supplemented and changed as necessary.)
- Act as an onsite project manager for dedicated hands-on project management and project controls monitoring of daily construction activities. Ensure the work is completed in accordance with contract documents.
- Provide on-site oversight and support to the construction effort, ensuring all Engineering and EHS standards are followed.
- Forecast, manage, and track project budget, spend, and cashflow under global engineering oversight. Monitor and control the project budget, report any problem areas, and make recommendations for actions.
- Maintain project schedule and manage project sub-teams to adhere to schedule. Conduct regular site walks and monitor onsite safety requirements.
- Run weekly core team meetings, send meeting minutes, and ensure communication between contractor, site team, and global management to facilitate on-time and on-budget project delivery.
- Work with site operations leads to develop the equipment logistics plan for installation and start-up of new and relocated equipment. Plan utility connections between process equipment and building systems.
- Support the development of facility system commissioning test plans and oversee installation and delivery of all purchased items.
- Oversee contractor daily activities and ensure compliance with the project quality plan. Coordinate with vendors and building maintenance personnel.
- Write, review, and revise a variety of documents including SOPs, validation/verification master plans, guidelines, execution plans, and commissioning test procedures. Maintain documented records of inspections, preventative maintenance activities, and any repairs.
- Manage issue logs, critical action logs, and escalate issues as required. Ensure compliance with the Document Storage/Collaboration/Communication plans.
- Monitor safety requirements by attending safety meetings, recording action items, and ensuring compliance with industry standards and Owner requirements.
- Monitor the Contractor’s adherence to the Quality Management Plan (QMP) and ensure all validation activities comply with GMP regulations and internal quality standards.
- Facilitate stakeholder engagement and ensure all relevant parties are informed of project status, issues, and outcomes. Present monthly project updates to the project governance team.
- Manage all substantial completion and final completion project closeout and turnover activities. Conduct final inspections and ensure all closeout documents are submitted in accordance with contract documents and client closeout requirements.
QUALIFICATIONS AND REQUIREMENTS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
Education:
- Bachelor’s degree in Engineering, Construction Management, or a related field.
Technical Experience:
- Significant experience and familiarity working with Manufacturing Construction projects on critically time-sensitive complex capital projects.
- Proven experience in project management, construction management, and project controls.
- Knowledge and experience working with FDA cGMP, FMEA, and Risk Analysis.
- Experience with equipment installation, commissioning, and validation (IQ/OQ/PQ).
- Strong background in budget management, schedule management, and vendor management.
Knowledge, Skills, and Abilities:
- Strong verbal and written communication skills and the ability to discuss technical topics with non-technical people.
- Ability to work collaboratively with cross-functional teams to achieve operational goals.
- Strong organizational skills and attention to detail.
- Excellent leadership and team coordination skills.
- Proficiency in project management software and tools.
ESSENTIAL FUNCTIONS:
Physical Demands:
The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.
TOTAL REWARDS PROGRAM:
We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere”. However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.
COMPENSATION:
Our compensation reflects the cost of labor across several US geographic markets. The base pay for this position ranges from $138,090.85 yearly in our lowest geographic market up to $207,136.27 yearly in our highest geographic market. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.
Applicants must have current work authorization when accepting a position at Syner-G. Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.
LEGAL STATEMENT
Syner-G BioPharma Group and Sequoia Biotech Consulting are proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G BioPharma is an E-Verify employer.
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