Posted:
9/4/2024, 9:00:00 AM
Location(s):
Connecticut, United States ⋅ Groton, Connecticut, United States
Experience Level(s):
Junior ⋅ Mid Level ⋅ Senior
Field(s):
Operations & Logistics
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
You will be part of a multi-disciplinary team responsible for cGMP (current Good Manufacturing Practices) production of Phase I -III clinical drug product in our Drug Product Manufacturing facilities in Groton, CT. Primary responsibility is in performing daily manufacturing activities for oral solid dosage forms. Additionally, you will contribute to the development of batch and continuous manufacturing technology capabilities by supporting novel process development and process understanding studies. The successful candidate must demonstrate strong teamwork dynamics when interfacing with various groups (e.g., Operations, Quality, Tech Support) and a growth mindset. As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative team environment for your colleagues.
It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Responsible for manufacture of clinical and development batches of solid dosage forms using conventional or novel processes. (primary activity)
Includes equipment setup, manufacturing, equipment tear-down and cleaning
Perform in-process operational checks associated with clinical manufacturing (examples include Solid Fraction Determination and Disintegration testing).
Troubleshooting / manufacturing support during operation
Provide “hands-on” training for Manufacturing Technicians and contribute to department technical/GMP/safety training.
Assist with Equipment Lifecycle Management activities.
Support and implement operational improvements throughout the manufacturing workstream (e.g., with regards to safety, quality, and efficiency)
Ensure all operations are executed according to Pfizer and OSHA safety standards.
Capture and share detailed post-manufacturing feedback.
Support creation and control of GMP batch documentation:
Assist in preparation of development batch records, working batch records, and review of executed batch records.
Author or revise standard operation procedures (SOPs)
Present to partner lines during pre and post manufacturing reviews, highlighting critical manufacturing information.
Identify and support the resolution of quality concerns; may assist with investigation reports in the quality system.
Utilize Pivision, Spotfire, and other software tools to create relevant dashboards and knowledge management tools
Qualifications
Must-Have
Bachelor's degree in chemical/bio-medical engineering or equivalent plus 2 years or less of experience in Manufacturing, Tech Transfer, continuous improvement, and engineering design.
Demonstrated experience in a biotechnology manufacturing or laboratory environment.
Ability to execute against Standard Operating Procedures and document entries in a compliant manner.
Strong interpersonal skills and accountability in day-to-day interactions with an operational focus on business goals, customers and process required.
Maintains a safe work environment.
Excellent oral and written communication skills.
Strong analytical and computer skills.
Nice-to-Have
Prior experience in a solid oral dose manufacturing environment
Experience with data visualization software (i.e. Spotfire, Pivision, or Tableau)
PHYSICAL/MENTAL REQUIREMENTS
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
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.
Website: https://www.pfizer.com/
Headquarter Location: New York, New York, United States
Employee Count: 10001+
Year Founded: 1849
IPO Status: Public
Last Funding Type: Post-IPO Debt
Industries: Biotechnology ⋅ Health Care ⋅ Medical ⋅ Pharmaceutical ⋅ Precision Medicine