Clinical Process Technology Sr Associate
Location
Sanford, NC | United States
Job description
Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and thedelivery of safe and effective products to patients.Our science and risk-based compliant quality culture is innovative and customer oriented. Whether you are involved in manufacturing, testing, or compliance, your contribution will directly impact patients.
In this role you will be 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.
You will work independently as part of a cross functional team . You will be responsible for the design, scale-up, implementation, tracking and reporting of manufacturing processes for clinical and product launch campaigns for gene therap ies and monoclonal antibodies.
What You Will Achieve You will be a member of Pfizer's dedicated monoclonal antibod y and gene therapy technical transfer t eam . As a Clinical Process Technology Sr Associate you will help to bring new medicines to market .
How You Will Achieve It - 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.
- Provide process engineering knowledge in process design from initial design specifications through implementation including testing during engineering projects.
- 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.
- Analyze root causes of process problems including but not limited to equipment failure, instrument malfunction, automation changes, and recommend technical solutions.
- Create, edit, and maintain SOPs, Master Batch Records and Compounding Records needed for new processes within the document management system.
- 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.
- 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.
- 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.
Qualifications Must-Have - Applicant must have a High School Diploma (or Equivalent) and 8 years of relevant experience OR an Associate's degree with 6 years of experience OR a Bachelor's with at least 3 years of experience OR Masters with more than 1 year of experience.
- Demonstrated experience in process or quality engineering in a pharmaceutical / medical device setting
- Demonstrated technical capability and aptitude for technical learning
- Familiarity with the operation of cell culture and/or purification technology
- Effective communication skills
Nice-to-Have - Degree in either of the following discipline: chemistry, biochemistry, biotechnology, chemical engineering or equivalent science related field or engineering discipline
- Previous experience executing as a Technical Services Scientist: Product transfers, Process and Cleaning validation experience.
- Experience with Single Use Bioreactors
- Validation and analytics knowledge
- Sound understanding of statistical experimental design and analysis.
- Experience with FDA regulations.
Physical/Mental Requirements: - Position requirements are typical for an office-based work environment with some lab floor exposure and clean room gowning will be required.
- Ability to work on own initiative.
Non-Standard Work Schedule, Travel, or Environment Requirements - Schedule is primarily day shift (M-F, 8 hrs), 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 day to Apply: February 27th , 2024
- Eligible for Relocation Assistance: NO
- Work Location Assignment:On Premise
The annual base salary for this position ranges from $78,000.00 to $130,000.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 10.0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
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. This position requires permanent work authorization in the United States.
Engineering
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