27 days old

Process Technology Manager

Pfizer
Sanford, NC 27330
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**ROLE SUMMARY** The incumbent works as part of a team to perform scientific, operational and process engineering tasks as they relate to technology transfer, scale-up operations, capital projects and routine manufacturing support. The incumbent should have the cross-functional scientific ability/skills/knowledge in the areas including fermentation/recovery, purification and conjugation chemistry.

The incumbent works with minimal direct supervision and is responsible for leading and executing optimization, implementation, troubleshooting, tracking and reporting of a variety of manufacturing processes for clinical and commercial production of microbial and conjugate antigen programs. The incumbent must maintain GMP documentation essential to documenting the manufacture of clinical grade materials. The incumbent must also comply with applicable safety, occupational health, loss prevention and environmental requirements.

The incumbent serves as the technical lead for a commercial products



**ROLE RESPONSIBILITIES**

As microbial and conjugate antigens progress through the research pipeline from Development through Phase III clinical production, the incumbent will work with internal and external development colleagues to map processes to the manufacturing facilities. This includes the following:



+ Review, recommend and execute process improvements and optimizations to existing processes with engineering principles (i.e. SIP/CIP optimization, cycle time reduction, equipment efficiency, PAT, CPV, APR). Analyze root causes of process problems including but not limited to equipment failure, instrument malfunction, automation changes, and recommend technical solutions. Develops guides and executes implementation of solutions to complex process engineering problems.

+ Serves as the technical lead for commercial products by serving as the point of contact for manufacturing. Ensures relevant technical information is relayed to group members and manufacturing colleagues, and solicits these personnel for feedback and improvement. Works with manufacturing to ensure production efficiencies.

+ Understand and provide input to the development of detailed process flow diagrams and step-by-step process fits of unit operations. May create, edit and maintain SOPs, Master Batch Records and Compounding Records as needed for commercial production within the approved QA document management system. Lead the revision process of documents as needed

+ Collaborate with development personnel during engineering practice runs. Ensure that the process adjustments are incorporated into the appropriate final version of SOPs, Master Batch Records and Compounding Records. Provide suggestions for innovative approaches to scale-up issues related to new projects. Incumbent must be able to recognize unique differences among different antigen processes and contribute to the scientific team that works through the issues encountered. Incumbent is aware of new process parameters co-developed with colleagues and is able to introduce them into the process with area champion or supervisor input.

+ The incumbent interacts with all functional groups at the site but would have primary interactions with engineering, manufacturing science and technology (MSAT), manufacturing and quality. The position also interacts with contacts at other PGS sites and center functions as well as PharmSci for new product/tech transfer activities.

+ Coordinates the development and execution of studies to identify, resolve and/or correct manufacturing problems or process improvements, producing reports to substantiate findings, and establish validation acceptance criteria.

+ Participates in all internal and external audits related to validation activities.

+ Takes a leadership role in cross-functional teams to resolve problems to optimize output, minimize contamination, and minimize cost.

+ Provide effective leadership and direction to Technical Operations personnel; build and develop talent and work with the regional/global teams to ensure key talent is developed across locations/businesses

+ Support and enhance the technical capability of the manufacturing environment including process control and improvement. Implement process control and reporting tools to ensure process trends are reviewed in a timely manner

+ Interact with Manufacturing Operations, Engineering and Product Development groups to proactively assess people/facilities capabilities and capacity

+ Ensure consistency of application of validation concepts across the site and the network.

+ Accountable for ongoing compliance of all process and cleaning validation activities with cGMP requirements.

+ Provide day-to-day support for technical issues in Mfg

+ Adhere to site safety standards, participate in routine safety training events, and enforce safety and biosafety requirements as they relate to the Clinical Manufacturing department.

+ Adhere to site SOPs and cGMPs for production activities in the manufacturing facilities.

+ Review company and site-specific SOPs, policies, and procedures and develop processes that meet the quality requirements set forth in these documents.



**BASIC QUALIFICATIONS**



+ BS degree + 8 years of experience is required, or MS + 4 years of experience or PhD + 0-4 years of experience is required. in any of the following disciplines: Chemistry, Biochemistry, Biotechnology, Chemical Engineering, Chemistry, or equivalent science related or engineering discipline.

+ Knowledge of the manufacturing process and equipment, preferably bacterial fermentation, purification and protein conjugation processes. Unit operations that include fermentation, centrifugation, hollow fiber filtration, depth filtration, UF diafiltration/concentration, column chromatography, lyophilization, and dispensing operations.

+ Direct knowledge and experience in manufacturing execution and tech transfer within a Biopharmaceutical/pharmaceutical cGMP environment.



**PREFERRED QUALIFICATIONS**



+ Experience in automation including DeltaV and equipment validation is desired.



**PHYSICAL/MENTAL REQUIREMENTS**

Some standing, ladder climbing, bending, pushing and lifting (up to 40 lbs.) may be required on a daily basis when the colleague is supporting work in manufacturing. Other job functions require working in an office setting where sitting and computer usage would be the norm.



**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**

Schedule is primarily day shift, but at times it will be necessary to work according to the manufacturing shift schedules (1st, 2nd or 3rd shift) to support execution of batch records when manufacturing batches during a tech transfer.



**Other Job Details:**



+ **Last Date to Apply for Job: 3/27/2020**

+ Eligible for Relocation Package

+ Eligible for Employee Referral Bonus



**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.



Engineering
Posted: 2020-03-02 Expires: 2020-04-23

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Process Technology Manager

Pfizer
Sanford, NC 27330

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