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Process Technology Sr. Associate


Sanford, NC
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Job Details

Job Title Process Technology Sr. Associate

JobID 1614093

Location: Sanford, NC

Description **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 to work in any of the clinical production areas including fermentation/recovery, purification and conjugation chemistry. Although the incumbent may be hired to work primarily in a particular area, they are expected to have the scientific acumen to quickly adapt to cross-functional training as needed to advance pipeline projects.

In addition, the position will provide support for process validation, cleaning validation and process analytics related to CPV. Direct interaction with regulatory authorities during audits.

The incumbent works with some direct supervision and is responsible for the executing the design, optimization, implementation, troubleshooting, scale-up, tracking and reporting of a variety of manufacturing processes for clinical and launch campaigns of microbial and conjugate antigen programs. The incumbent must also be able to maintain GMP documentation essential and documenting the manufacture of clinical grade material. The incumbent must comply with applicable safety, occupational health, loss prevention and environmental requirements.


+ Participate in clinical product transfer, production and capital projects in a technical capacity. Perform technical transfer and process engineering activities by working with senior level colleagues and supervision to implement processes in the manufacturing areas. This may include assisting in technical transfer of processes from development laboratories and small-scale pilot areas into the clinical production areas, as well as technical transfer from clinical to commercial facilities.

+ As microbial and conjugate vaccine candidates 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 which may be performed in collaboration with or guidance from senior level colleagues:

1. Provide process engineering knowledge in process design from initial design specifications through implementation including testing during engineering projects. Collaborating with the Site, Engineering & Maintenance (SEM) department and outside engineering firm personnel will be critical to successful outcomes. Assist in developing new process procedures (i.e. CIP/SIP paths, WFI flush, blowdown, waste removal, stat paths) and review closely with SEM automation team and Technical Operations team. Perform calculations to ensure correct equipment sizes are in place for new processes. Assist in procuring process equipment. Develop process flow diagrams for illustrating critical process and material flow.

2. 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). 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.

3. Understand and provide input to the development of detailed process flow diagrams and step-by-step process fits of unit operations. Create, edit and maintain SOPs, Master Batch Records and Compounding Records needed for new processes within the approved QA document management system. Lead the revision process of documents as they evolve during the technical transfer and development process. Track approval of new and revised documents through the QA document approval process.

4. Collaborate with development personnel during engineering practice runs to introduce a variety of product candidate processes into clinical production areas through effective process scale-up and troubleshooting activities. This includes adjusting process parameters as necessary during engineering runs and pursuit of any necessary equipment/automation refinements to ensure optimized process performance prior to demonstration 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.

5. Maintain careful and accurate records of process and analytical data and findings on development projects. Utilize data and findings to contribute to meetings and make presentations on specific process issues. Provide observations/comments during schedule planning and process development meetings. During demonstration and clinical production campaigns, the incumbent will function as the process subject matter expert and will execute batch production and provide leadership to the manufacturing teams. The incumbent will also perform real-time troubleshooting of equipment and process operations to ensure successful batch completion.

6. Maintain equipment and automation proficiency. Execute equipment preparation and operation in controlled and classified areas. Work with colleagues and available resources/literature to solve problems with input from area champion or supervisor as needed. Operate the following types of process equipment: fermenters, recovery equipment, ultrafiltration/diafiltration skids, depth filtration equipment, chromatography skids, fixed and portable vessels, lyophilizers, and cleaning equipment. Submit samples to QC and enter sample information into the approved quality laboratory information management system.

+ Procure, test, and operate equipment and computer controls within the clinical production areas. This will include the following:

1. Gain familiarity with existing and newly developed processes in order to produce a variety of product candidates within the clinical product space. Participate in conceptual and detailed facility design, equipment design and procurement, and computer control system design and review. Develop ability to read P&ID diagrams and compare with as-built field construction. Contribute to resolution of outstanding detailed design and logistics issues in order to prepare for smooth commissioning, validation, and start-up of the facility, equipment, and control systems.

2. Identify and resolve any operating issues that exist with the equipment during execution of operational qualification protocols in order to ensure flexible, efficient, and compliant use of the equipment. Analyze and interpret any equipment operational results in collaboration with cross-functional staff.

3. Utilize detailed understanding of processes, equipment, facility, and distributed control system and cGMP requirements in order to write SOPs for functional area and general procedures. Facilitate review, approval, and implementation of these new SOPs.

+ Validation and Analytics

+ Responsible for participating in the execution of process and cleaning validations as well as related activities and projects including continued process verification. This includes generation of protocols, execution, gap assessments, direct sampling of equipment and process, obtaining data from LIMs, and the analysis of data for CPV. Direct interaction with regulatory authorities during audits.

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


+ A minimum of a BS degree in either of the following discipline: chemistry, biochemistry, biotechnology, chemical engineering or equivalent science related field or engineering discipline. Four to 7 years of experience; or equivalent combination of education and experience is required for this position.

+ 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. Experience in automation including DeltaV and equipment validation is a plus.

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

+ Validation and analytics knowledge is a plus.


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.


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.

**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.

+ **Last Date to Apply for Job: 27 October, 2017**

+ **This job is (Pfizer) (Exempt) (US/PR) Grade: 007**

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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