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Manufacturing Team Leader


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Job Details

The Team Leader is responsible for leading a team during the manufacturing of GLP and GMP Phase I/II clinical products within the production facility. Responsible for adhering to timelines and coordinating with sr. management to ensure that plans are clear and realistic, with respect to manufacturing schedules. The role requires demonstrating innovative technical knowledge and assisting production teams in identifying and managing continuous improvement initiatives. The individual will remain current on Good Manufacturing Practices (cGMP) guidelines and will use expert knowledge of compliance to implement risk management practices for mitigating risks associated with product quality. Lead staff to demonstrate best practices in manufacturing, safety, compliance, investigations, and procedures, in addition to demonstrating strong supervisory skills and contributing to the achievement of company and departmental objectives.

+ Successfully manages production activities related to GLP and GMP production of pre-clinical and clinical products, both drug substance and drug products.

+ Participates in determining objectives of assignments and ensures the assignments are completed in a high quality, compliant, and timely manner.

+ Utilizes manufacturing process knowledge and investigation skill sets to identify and resolve manufacturing issues, improve process operations, and affect positive change.

+ Works with cross functional teams to drive investigation close outs, determine root causes, and implement appropriate corrective and preventative actions as needed.

+ Ensures staff has appropriate technical understanding of current manufacturing processes and staff training requirements are current on processes and procedures, including annual cGMP and QA SOPs

+ Provides leadership, guidance, and direction to staff consistent with cGMP and company guidelines.

+ Adheres to Company safety procedures and guidelines by practicing and promoting safe work habits. **Qualifications** Education: BS or MS Chemical/Biochemical Engineering, Biology, Biochemistry, or related discipline is required. **Experience**

+ Five (5) years of experience is required as well as one (1) year of experience in a lead or supervisory role.

+ A strong working knowledge of the regulatory compliance requirements in a cGMP environment and understandings of scientific principles in order to problem solve and troubleshoot test results.

+ Strong practical and theoretical knowledge of bioprocess unit operations. Familiarity with viral vector production is a plus. **Skills and Abilities:**

+ The successful candidate will possess strong interpersonal, teamwork, and collaboration skills. In addition, possesses strong workload planning skills, organization, and attention to detail, and follow through.

+ Problem-solving and trouble shooting skills are essential.

+ Must have excellent written and verbal communication skills.

+ Ability to prioritize and multi-task concurrent project demands.

+ Strong computer skills in Microsoft Office required e.g. MS Word, MS Excel **NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS** 2nd Shift position - Sunday nights thru Friday night 8 hours **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. **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.

**Additional Offer Details:**

- This job is Pfizer Exempt US/PR Grade: 008

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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