Prin Research Scientist II

Principal Research Scientist II - Bio
JOB SUMMARY:
Conduct process development to ensure timely development of robust Fermentation and Recovery procedures for new protein and polysaccharide vaccine candidates as well as production of clinical trial materials in cGMP pilot plants. Operate with a high degree of independence and exercise creativity and good scientific judgement in managing new product development projects. Colloborate with Operations, Regulatory Affairs, Quality, Technical Services, and Engineering to effectively transfer new manufacturing technologies to production.
JOB ACCOUNTABILITIES:
Develop, optimize, and qualify appropriate growth medium for microbial fermentation which are grown in order to produce vaccine antigens.
Develop, optimize, and qualify appropriate fermentation and recovery processes for microbial fermentation which are grown in order to produce vaccine antigens.
Determine appropriate control ranges and identify optimum process parameters for fermentation and recovery process.
Record all experimental results in the laboratory notebook in accordance with corporate and site policy. Summarize data in weekly, monthly, or quarterly reports as required.
Qualify fermentation processes by using appropriate in-process assays to identify critical process steps and parameters.
Develop and qualify in-process assays for important fermentation inputs and outputs. These in-process assays may include those for raw component analysis, product attributes, contaminating bio-molecules, and residuals such as substrates or added chemicals.
Safety- Adhere to site safety standards, participate in the routine safety training events, and enforce safety/chemical hygiene requirements as they relate to the Bacterial Vaccine Process Development labs and pilot plants.Compliance- Ensure adherence to cGMP requirements and full training in relevant policies and procedures.Quality- Ensure that Bacterial Vaccine process development is conducted in accordance with current Good Manufacturing Practices, the company's R &D quality goals and sustainable compliance initiatives, as well as the company's mission, vision and values.Perform all duties in a manner consistent with site and corporate cGMP, safety, environmental, and human resources policies and procedures.
EDUCATION/EXPERIENCE/REQUIREMENTS:
This position requires a PhD or Masters degree in biochemical engineering, microbiology, or related field.
A Ph.D. degree and two years of relevant development experience or a Masters degree with four or more years of relevant development experience is required for this position. Incumbent must have a thorough knowledge of fermentation or recovery processing in the area of biotechnology or biopharmaceutical new product development. The ability to effectively communicate research results in written and verbal format to colleges and supervision is required.Wyeth offers competitive compensation and benefits programs including stock
options, child-care subsidies, flex-time, business casual attire,
educational assistance and professional development programs. Please
forward your resume with salary requirements and job reference code to the
address below.For more information, visit our website at