PRINCIPAL SCIENTIST Job in Fort Washington, Pennsylvania Us
McNeil Consumer Healthcare Division of McNEIL-PPC, a member of Johnson Johnson's Family of Companies, is currently recruiting for a Principal Scientist located in Fort Washington, PA.
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc markets a broad range of over-the-counter products, including TYLENOL acetaminophen products, ZYRTEC and BENADRYL allergy medicines, IMODIUM A-D anti-diarrheal, MOTRIN IB, PediaCare upper respiratory medicines for infants and children, ROLAIDS antacid products, ST. JOSEPH Adult Regimen Aspirin, and SUDAFED nasal decongestants.
The Principal Scientist will lead analytical activities for complex new drug products by understanding pre-formulation studies, process validation studies, method development and validation, stability studies and process evaluation analysis. This individual will work with cross-functional teams to define requirements, deliverables and milestones to meet regulatory requirements, and assure business goals are met. The Principal Scientist will identify, evaluate, and implement new analytical technology as required for project activities. This individual will issue, review and approve technical documents including analytical method development histories, method validation protocols and reports, and stability reports in compliance with standard operating procedures and regulatory requirements. In addition, this individual will participate on cross-functional teams and recruit and mentor analytical Scientists.
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations, the Companies' policies, procedures and guidelines, this position will be responsible to ensure quality and compliance in all actions by attending GMP training on the schedule designated for this role and as appropriate for this role. This position must adhere to strict compliance with procedures applicable to this role; must exercise the highest level of integrity in all the tasks performed; in a timely and prompt manner, identify, report and seek correction for deviations noted in the workplace and will embrace a behavior of employee involvement and commitment to doing the job right the first time.
Qualifications
A minimum of a Bachelor's degree and 9 years of analytical chemistry experience OR a Masters and 7 years of analytical chemistry experience OR a PhD and 4 years of analytical chemistry experience is required. A focused degree in Chemistry or related field is preferred. Experience in working within a Pharmaceutical or Regulatory environment is required. Experience in HPLC/UPLC and GC methods development/validation is required. Experience with ICP and/ or CE methods development/validation is desired. Previous experience in working with Quality and New Product Development teams is preferred. Strong knowledge of GMPs is required. Experience interacting with the FDA, EPA, and/or DEA during audits and inspections is preferred. Broad knowledge and experience with regulatory requirements including ICH and FDA is highly preferred.
Strong written and oral communication skills are required. It is required that this candidate have strong technical writing skills with understanding of compliance both from quality and regulatory standpoint. This individual will be able to work independently, while managing multiple priorities successfully. The ability to influence others is highly preferred.
This position will be based in Fort Washington, PA. This position will require up to 15% domestic and international travel.
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