Why Patients Need You
Our 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.
What You Will Achieve
In your role, you will perform Manufacturing operations for the production of
clinical batches for investigational study purposes. Your work will involve biological manufacturing, which includes, but is not limited to, fermentation, cell-culture, purification, and and separation techniques operations.
As part of the Andover Clinical Manufacturing team, you are recognized as a subject matter expert with specialized knowledge and skills in procedures, techniques, tools, materials and equipment associated with Upstream and Downstream Drug Substance manufacturing. You will be entrusted with adapting standard methods and procedures by applying your knowledge, prior work experience and requirements. Your business awareness of cross-organizational impact on project delivery will elevate the quality of project deliverables. You will make decision about the methods and procedures that are the best fit for different work situations. You will train others and reinforce behaviors that will help us achieve our goal of providing the best healthcare to our patients.
It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Manage own time, professional development and be accountable for own results.
Prioritize own workflow, allocate work to othersand assist in establishing their priorities.
Support/perform support operations in the manufacture of clinical drug substance per approved Batch Records and SOPs.
Perform some in-process testing, perform in-process sampling and sample handling.
Exhibit broad working competence level for all core operating tasks and exhibit knowledge and ability to operate more complex processing equipment [bioreactors, fermentors, chromatography and tangential flow filtration skids].
Conform to Environment, Health and Safety (EHS) guidelines and regulations. Maintain a safe work environment for all.Contribute to the review and implementation of the compliance and EHS practices in the plant.
May perform Validation activities, including equipment qualification and commissioning of equipment used in cGMP (current Good Manufacturing Practices) operations.
Coordinate and oversee the daily work of operations team members, when directed by Operations Manager or Leads.
Collaborate with Quality, Engineering, Process Development, Validation and Operations to resolve manufacturing events in a timely manner.
Assure appropriate escalation to various levels of management when personnel and environmental safety, equipment functionality, product supply, or quality are at risk.
Remain current on all training requirements and completeall required procedural and skills training prior to executing assigned tasks.
High School Diploma or GED and 6+ years of applicable experience in Drug Substance manufacturing.
Significant knowledge of industry practice for cGMP.
Problem solving and equipment and/or process trouble shooting skills.
Strong workload planning skills and organization.
Demonstrate excellent interpersonal and team building skills.
Strong Electronic Skills working with computers, databases, software, navigation of shared drives, search engines, word processing, spreadsheets.
Experience with Quality Management and Change Management Systems.
Experience working in a regulated environment.
Must be able to lift 25+ lbs.
Must be able to sit and stand/walk for extended periods of time in safety footwear.
Work requires ability to gown into a clean room daily (full coverall, boot covers, head cover, mask, gloves).
Ability to thrive in a dynamic environment with shifting priorities and flexible production schedule.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Some non-standard hours may apply as the process requires, but are not typical.
Occasional early or late hours, ability to work overtime as process requires.
Some weekend work as process requires.
Other Job Details:
Relocation assistance may be available based on business needs and/or eligibility.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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.