Why Patients Need YouOur breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them. It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.Sanford North is recently a new Pfizer facility that serves as a Clinical, Commercial, and Contract Development and Manufacturing Organization (CDMO) site. It is designed to cater to the diverse needs of the pharmaceutical, biotechnology, and life sciences industries, offering comprehensive services across various staged of drug development and manufacturing.Role SummaryThe Technical Lead functions as part of a multi-disciplinary team responsible for delivery of cGMP clinical and commercial products. The initial focus is on the start-up and readiness of a new mAb site, including, but not limited to, support of facility/equipment commissioning and qualification, creation of all associated cGMP procedures, design and procurement of processing aids and equipment, and training of operations colleagues.Post-site start-up, the successful candidate will support and execute cGMP mAb processing. Support functions may include owning and leading deviation and investigations, CAPA implementation, operational and continuous improvement projects.Role Responsibilities
Obtain technical expertise of equipment and processes in area of responsibility. This includes clear understanding of equipment flow chart/process flow document, critical process parameters, and master formula instructions for the process.
Supports operational and equipment problems and makes recommendations. Assists with changeovers and preventative maintenance activities with the facilities group.
Actively support campaign start-up with roles in technology transfer, site assessment, generation of cGMP documentation, area preparation, process execution and summary reporting.
Participate in Internal or External audits as subject matter expert for department.
Contribute to the completion of complex projects, time management to meet project deadlines.
Coordinates and drafts revisions of batch related documents, including batch records and SOPs.
Support procurement and validation of new equipment and technologies.
Maintain a contemporary understanding of biotech Drug Substance (DS) unit operations and related process monitoring & control tools.
Support in the resolution of technical problems through scientific understanding and application of innovative solutions.
Assist in writing, executing, and closing change controls and CAPAs related to the manufacturing process.
QualificationsMust-Have
Applicant must have a High School Diploma (or Equivalent) and 8 years of relevant experience OR an Associate's degree in engineering or scientifically related fieldwith 6 years of experience OR a Bachelor's degree in engineering or scientifically related field with at least 3 years of experience OR Master's degree in engineering or scientifically related field with more than 1 year of experience
Knowledge and skills with biologics manufacturing processes and equipment.
Knowledge and understanding of cGMP and how they apply to duties and responsibilities.
Ability to follow detailed instructions and to maintain accurate records.
Ability to work with minimal direction.
Strong problem-solving skills.
Organization skills to prepare team for operating multiple projects.
Ability to successfully multitask, when required.
Working knowledge and understanding of Microsoft Office Applications.
Nice-to-Have
Knowledge of single-use technologies, including disposable systems.
Experience interacting with regulatory agencies.
Experience in obtaining site licensure.
Physical / Mental requirements
Ability to sit or stand for extended periods of time.
Must be able to lift up to 30 lbs.
Ability to thrive in dynamic team environment with diverse perspectives.
Propensity for creative problem solving and courage to share and actively promote innovative ideas of self and others.
Non-Standard work schedule, travel or environment requirements
Ability to work nights and weekends, non-routine.
Ability to work in a clean room environment.
Ability to travel up to 10%.
Other job details
Last day to apply: March 12th, 2024
Employee Referral Bonus
Work Location Assignment:On PremiseThe 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 ActPfizer 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 EligibilityPfizer 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.Manufacturing#LI-PFE
