Job Description
Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
As the MSAT Analytical Lead, you are technically capable, fully independent and motivated to lead technical and innovative programs at the center of our operations. Your significant experience of applying knowledge of principles, concepts, and practices of the discipline will make you a critical member of the team. You will develop, design, execute, and complete scientific experiments for qualitative and quantitative analyses of organic, inorganic compounds, or biologics to determine chemical and physical properties in support of changes to drug product process, complex investigations, remediations programs and innovation initiatives.
As a Manager, you will provide supervision of scientists while ensuring all work is GSP fully GMP/GLP compliant. You will help your team members with solving complicated problems, designing experiments, delivering work assignments, reviewing and approving protocols/reports and preparing presentations for communication to key stake holders. You will be considered a technical expert and have a significant understanding of analytical chemistry, pharmaceutical formulation, and/or microbiology techniques. You will have demonstrated leadership skills and can make complicated personnel decisions and contributing to team member’s professional growth. You are proactive in contributing to all team discussions and creating an environment of collaboration.
It is your innovative scientific temperament that will help in making Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
- Develop and complete professional level chemistry and biochemistry studies independently in support of programs, exploratory/feasibility studies and investigations while demonstrating cGMP and scientific principles
- Preparing, reviewing and approve technical and regulatory documents including protocols, reports, technical assessments, Justifications, investigations, study plans, and meeting minutes, as needed
- Provide supervision to analytical team including delivering complex personnel decisions.
- Highly respected colleague; able to influence team members across the network for shared goals
- Providing technical subject matter expertise and issue resolution for major/ moderately complex investigations for aseptic sterile injectables, biologics and vaccines and assisting in completing all required documentation in a timely manner
- Participating in the Co-Development process, particularly in Late Stage Development/Phase 3 Clinical Supply to commercialization and continued product support
- Applies technical knowledge and skills to achieve goals of the department
- Contribute to achievement of immediate work group goals and collaborate with cross-functional team members
- Maintain a contemporary awareness of Global Business Practices, methods, specifications, Standard Operating Procedures, Pharmacopoeial trends, International Conference on Harmonization guidelines and regulatory expectations
- Assist in the management of the laboratory maintenance and continuous improvement of safe and effective working practices
- Independently carry out all aspects of practical work necessary to provide right first-time results.
- Perform analytical method development, validation and transfer activities for small molecules as well as complex formulations as required to support project timelines
- Maintain written records of all experimental work in accordance with Good Lab Practices/ current Good Manufacturing Practices (GLP/cGMP) and departmental Standard Operating Procedures
- Responsible for performing and troubleshooting chemical techniques, while applying these methods to a broad range of early and late-stage products in a cGMP environment
- Good influencing skills and ability to work in a matrix organization to deliver results
- Strong analytical, strategic and interpersonal skills. Ability to synthesize concepts independently and requirements and effectively communicate them to all PGS stakeholders
- Interfacing with and influencing diverse customers including site groups from PGS (Ops, Technical Services, Quality) and network groups such as External Supply, PD&S, PharmSci, VRU, GCMC
- Comfortable with multifunctional and multi-cultural environments
Qualifications
Must-Have
- Bachelor's Degree with 5+ years of Engineering (Mechanical, Chemical, or Pharmaceutical preferred) or Life Sciences Experience OR
- Master's Degree with 3+ years of Engineering (Mechanical, Chemical, or Pharmaceutical preferred) or Life Sciences Experience OR
- Associates Degree with 8+ years of Engineering (Mechanical, Chemical, or Pharmaceutical preferred) or Life Sciences Experience OR
- High School Diploma (or Equivalent) and 10+ years of Engineering (Mechanical, Chemical, or Pharmaceutical preferred) or Life Sciences Experience
- Strong background in sterile injectables/bios formulations and filling
- Operations or Tech services experience is a plus
- Knowledge of cGMP requirements and compliance
- Experience with laboratory data systems
- Excellent communication and technical writing skills
- Ability to manage own time to meet agreed targets and develops plans for short-term and long-term activities
- Ability to think creatively and find innovative solutions is a plus
- Able to independently design experiments and studies to answer complex scientific and technical issues
- Ability to extract relevant information from scientific literature, accurately record observations, facts, data and conclusions during experimental work or cGMP investigations.
- Good knowledge of fundamental organic chemistry, functional group recognition and compound characterization with some experience using spectroscopic and chromatographic techniques
- Interact effectively with peers and leaders as part of a multi-disciplinary team
- Effective verbal and written communication skills
Nice-to-Have
- Understanding of various scientific software or software used in pharmaceutical or production environment.
- Good Laboratory Practices/Good Manufacturing Practices knowledge.
- Motivation to independently develop their own technical skill set is essential.
Physical/Mental Requirements
- This position involves frequent work within an analytical testing lab, in the presence of chemicals, with appropriate Personal Protective Equipment (PPE). Occasional work within a cytotoxic analytical lab in the presence of potent and cytotoxic compounds is required (with appropriate PPE).
Non-Standard Work Schedule, Travel, or Environment Requirements
- This role is standard day Monday through Friday work shift; some weekends and nights may be required to support project work.
- Travel ~5%
Other Job Details
- Last Day to Apply: 30 May 2023
- Relocation support available
- Work Location Assignment: On Premise
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.
Research and Development
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