Operations Program Manager Jobs

Are you knowledgeable about GMP commercial manufacturing of API Small Molecules?

Can you define, execute, and oversee a project portfolio strategy?

Do you have a strong interest in continuous improvement and operational excellence?

Fraser Dove International has an exclusive partnership with a global leader in the development and manufacturing of APIs, specializing in highly regulated and complex chemistries. Their commitment is to foster strong customer relationships and provide solutions.

Our client is currently looking for an experienced leader to take charge of all activities related to the commercial production of exclusive products at their Massachusetts manufacturing site.

Your Responsibilities:

As the Operations Program Manager, your performance will be evaluated based on the following objectives:

1. Serve as the primary point of contact for customers regarding technical and project issues, collaborating closely with the site General Manager, site Technology Manager, Business Development, and the program core team to ensure the program stays on track and within budget.
2. Ensure departmental readiness for audits and participate in quality audits with the FDA and customers related to the program.
3. Adhere to all EH&S policies and procedures.

Your Duties:

As the Operations Program Manager, your role includes:

Principal Accountabilities:

• Independently manage projects with minimal oversight, interacting with all site functions (R&D, Operations, Commercial, QA/RA, Supply Chain, Finance) and exerting wide-reaching influence.
• Manage program communication, including weekly customer meetings, Quarterly Business Reviews, KPI tracking, project expenditures, and presentations to the Leadership Team.
• Work closely with Business Development to address out-of-scope deliverables and prepare project proposals.
• Act as the main liaison with commercial clients for technical and project matters, ensuring that program milestones align with established objectives, which may involve one or more clients based on program size.
• Develop, test, and implement continuous improvement initiatives to cultivate a high-performance culture.
• Drive a culture of achievement and accountability within the teams.
• Keep key stakeholders informed of program KPIs, plans, status, and decisions through regular reporting and communication.
• Foster strong, collaborative relationships with the team, ensuring that both customer and cross-functional team needs are met.
• Develop and adhere to the program budget.
• Collaborate with the Production Technology Manager to maintain the production schedule, address scheduling conflicts, and support manufacturing investigations.
• Identify and solve complex problems across various workstreams with interconnected parts.
• Lead and motivate a multi-disciplinary team, holding team members accountable for delivering results.
• Undertake other duties within your skill set and abilities as reasonably instructed.

Quality/ Regulatory Responsibilities:

• Ensure departmental audit readiness and participate in audits with the FDA and customers related to the program.
• Adhere to cGMP requirements.
• Comply with the organization's quality policies and practices concerning cGMP and related requirements.
• Demonstrate technical expertise and confidence in applying cGMP standards.

Environmental, Health, & Safety Responsibilities:

• Actively participate in root cause investigations related to near misses and incidents linked to the program, ensuring that corrective actions are implemented in compliance with Company policies, procedures, and state and federal regulations within the responsible department.
• Comply with all appropriate EH&S policies and procedures.
• Be ready for departmental audits and participate in audits with internal Company groups, regulatory agencies, and customers related to the program.
• Display technical and procedural expertise and self-assuredness in applying EH&S policies and procedures.

Physical Demands & Work Environment Responsibilities:

• Occasional domestic travel within the US for technical meetings, customer visits, team briefings, and supplier contacts.
• Primarily work in an office environment, with occasional walking, standing for extended periods in labs/plants, kneeling, reaching, handling, twisting, and bending at the waist as needed for the job.

Your Qualifications:

To excel as the Operations Program Manager, you should possess the following skills and experience:

• Demonstrated project management skills and application of best practices.
• Strong interpersonal skills, the ability to influence and motivate without formal authority, and the capability to build productive relationships with key stakeholders.
• Proficiency in MS Office applications, including Word, Excel, PowerPoint, and SharePoint.
• Familiarity with cGMP standards related to drug substance manufacturing is a plus.
• Ability to prioritize, plan, and lead project teams.
• Effective collaboration across all organizational levels, including executive management.
• A bachelor's degree in Chemistry, Chemical Engineering, or a related discipline, with a minimum of 5-7 years of hands-on experience in process, analytical, or manufacturing, along with 5-7 years of progressively complex project management experience.
• Experience with the regulatory aspects of the drug approval process is advantageous.
• Preferred experience in a Contract Manufacturing Organization.

Got what it takes?

To apply for the Operations Program Manager, click the ‘Apply’ button below or contact the Executive Search Consultant – Rosey Grant – on +44 (0)203 355 7050.

Please Note:

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorised to give instructions or assignments.

If you have not heard from an Executive Search Consultant within ten working days from the date of your application, please consider yourself unsuccessful on this occasion.

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Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. Passionate about people, we take pride in helping exceptional life science organisations source the talent they need to design, manufacture and distribute life-changing drugs, treatments and devices which transform and save patient lives.