Sr Director, Manufacturing
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
I. JOB SUMMARY
Provides leadership for the Upstream and Downstream Manufacturing Teams. Plans and coordinates production within several manufacturing suites – manages the production schedules for multiple suites. Sits on the Site Management Team and works closely across several functions to ensure effective operations of cGMP manufacturing.
II. ESSENTIAL FUNCTIONS
• Responsible for leading manufacturing operations and managing both planning for production at Bayview.
• Responsible for leading managers and building the manufacturing organization.
• Ensure that bulk or final drug products are manufactured with strict adherence to the cGMPs.
• Collaborate with PAD or MSAT teams for effective technology transfers.
• Develop and maintain a well-trained and compliant manufacturing work force.
• Assist with audits and inspections both internally and externally. Ensure compliance with US/EU regulations.
• Establish production schedules and ensure resources are adequate to meet the demands of the production schedule.
• Provides technical guidance for complex manufacturing operations.
• Ensure a safe work environment for the operations group and maintain effective manufacturing controls.
• As required act as liaison with Contract Manufacturing Group in support of bulk drug substance manufactured or final drug product filled at a Contract Development Manufacturing Organization.
• Communicate, support and meet corporate and site goals and objectives.
• Evaluate the performance of direct reports and providing regular performance feedback and coaching.
• Develop and manage Capital Expenditure Plan for Manufacturing.
• Ensure adherence to cost center (OPEX) budget.
• Develop and maintain performance metrics for site manufacturing activities.
• Champion for continuous improvement and operational efficiency in an effort to eliminate waste and reduce COGS within the manufacturing operations.
• Communicate department progress to management and staff.
• Assign, and ensure, timely execution of project tasks and job task completion.
• Provide document oversight and review.
• Collaborate to close Deviations and CAPAs.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
• Minimum BS in a Life Sciences or Engineering, MS a plus.
• A minimum of 10 years experience working in a biological vaccine/therapeutic manufacturing environment with at least 3 of those years in a mid-to-upper level management capacity.
• Extensive knowledge of cGMP and CFR requirements.
• FDA / CBER experience required with CDER experience preferred.
• Demonstrated leadership abilities and strong interpersonal communication skills are a must.
• Strong oral/written communication skills.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.