Senior Research Scientist - Analytical Chemist -22418

Newly refurbished R&D lab looking for a Senior Research Chemist to do Analytical Chemistry regarding leachable plastics and chemicals for pharmaceutical applications

Responsibilities: Essential Duties

•           Lead and coordinate high impact PLCM activities for development of next generation product platforms for therapeutic drugs and infusion fluids business segment, in addition to maintenance of current commercial products in compliance with USP / FDA / ICH and related regulatory expectations.

•           Design laboratory studies, and prepare technical justification reports for material selection, deployment and control plans (alternate API, excipients, IV container closure materials such as resin, stoppers, inks, adhesives, etc.).

•           Lead technical investigations and risk assessments for product, materials and process changes (e.g. supplier or DMF changes) and collaborate in development of regulatory strategies and authoring CMC related documents (PAS, CBE-0, CBE-30).

•           Provide SME inputs for material specification justification, setting, monitoring and harmonization.

•           Build networks with contract labs and CRO’s to conduct analytical testing, safety-toxicological assessment, biocompatibility studies, and compliance evaluations.

•           Lead internal and USP initiatives related to API and Product Monograph authoring and revisions.

Expertise: Knowledge & Skills

•           A Ph.D. degree in Analytical Chemistry, Organic Chemistry, Toxicology, Pharmaceutics, or a related discipline is required.  Pharmaceutical Industry (or combination of industry + post graduate research experience) of 12-15 years in one or more areas related to sterile products development, product life cycle management (chemistry), material biocompatibility, toxicology, and extractable-leachables (stoppers, polymeric resins, labeling material, containers) is desired.

•           Must be able to provide subject matter expertise in interpreting the FDA, ICH, EMA and related regulations, work with cross-functional teams, develop strategies, and implement research studies to meet product PLCM management objectives.

•           Hands-on expertise in Analytical Technologies, including HPLC, GC, UV, FTIR, MS, NMR and complex analytical instruments is required.

•           Must have strong verbal communication and expert technical writing skills as demonstrated by technical posters, presentations and manuscripts.

•           Requires full working knowledge of professional field and industry. Influences the development of and drives the application of principles, theories, and concepts. Determines best course of action.

•           Working knowledge of USP, EP, cGMP/GLP, FDA CFR & ICH regulations and guidelines.

•           Strong working knowledge of chemical theories, concepts, test methods and instrumental methods.

•           Advanced analytical and research skills

•           Works under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, assigning & checking the work of lower level employees. Referring only complex problems and issues for superiors review or approval.

•           Judgement is required in resolving complex problems based on experience

•           Contacts are primarily with direct supervisor, peers and subordinates.

Qualifications

Expertise: Qualifications - Experience/Training/Education/Etc

Required:

•           PhD in related science required

•           12-15 years related experience.

•           Applicable industry certification preferred.