Sr. Manager Manufacturing- Drug Substance/Active Biological Ingredients
Pfizer Inc.
Andover, MA
Job posting number: #7145178 (Ref:pf-4884573)
Posted: May 11, 2023
Application Deadline: Open Until Filled
Job Description
Why Patients Need You
Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative teams, you will help bring medicines to the world even faster by imagining what’s possible and taking action.
What You Will Achieve
Working in a Manufacturing organization which is responsible for manufacturing Active Biological Ingredients.
The people leader of the Engineer/Scientist group in manufacturing operations is responsible for management of a group whose primary focus is on right first time, technical assessment of processes including technology transfer, maintaining a culture of compliance, innovation within their assigned Asset Group.
The people leader will need to guide the people within their group as well as the asset as a whole on compliance knowledge and technical knowledge to lead manufacturing related tech transfer activities, lead troubleshooting activities, provide investigations support, analyze process data, and identify and implement process improvements to drive continuous improvement efforts cross- functionally.
Act as a voice of manufacturing
How You Will Achieve It
Management and coaching of group tailored to the specific skill sets and focus of the individuals.
Guidance on knowledge and technical transfers.
Guidance, review and approval of change controls, protocols, procedures, and MBRs.
Oversight and management of training requirements.
Promotion of an innovative culture.
Sustainable program participation and guidance.
Validation strategies, Change management, etc.
Process monitoring – real-time and trend analysis.
Achieve plan of record (POR).
Drive towards achieving metrics; communicate results.
Manage within budget.
Coordination of responsibilities with other groups.
Communication and delegation of responsibilities within group.
Technical Oversight of campaigns and projects to ensure expected performance.
Mentor and coach group for continual advancement.
Maintain knowledge of current industry best practices.
Ensure adequate communication of performance to external groups (PharmSci, Product Tech Team, etc.)
Support of the safety program.
Oversight of individual responsibilities.
Communication of messages, changes in procedures, etc.
Resolution of issues to ensure a safe operating environment.
Ensure adequate resolution of operational variances, investigations, etc.
Support regulatory filings as needed.
Support of audits including walkthroughs, response, and driving closure of any observations.
Provide support during audits and with audit observation closure.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
QUALIFICATIONS
Must-Have
Bachelor of Science degree in Science or Engineering with 10+ years of pharmaceutical/biopharmaceutical industry experience or
Masters with 7+ years of pharmaceutical/biopharmaceutical industry experience or
PhD with 5+ years of pharmaceutical/biopharmaceutical industry experience
Prior managerial and team leadership experience.
Desirable:
Previous extensive experience in a GMP manufacturing environment.
Familiarity and experience with biotech/mammalian cell culture, centrifugation, and ultrafiltration.
Familiarity and experience with downstream purification process such as UF/DF, and Chromatography experience.
Experience with Six Sigma, 5S and/or other operational excellence programs a plus.
Familiarity with aseptic technique and microbial control a plus.
PHYSICAL/MENTAL REQUIREMENTS
Work will include walking throughout the manufacturing suite, including up and down stairs.
Perform mathematical calculations and ability to perform complex data analysis
Ability to don cleanroom gowning
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
The role requires work in a GMP manufacturing suite which requires gowning.
Occasional travel might be required.
Other Job Details:
Last Date to Apply for Job: May 24th, 2023
Work Location: Flexible
Relocation Support Available
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
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