Principal Scientist, R&D-Aseptic Development

Proclinical is seeking a Principal Scientist, R&D-Aseptic Development for a leading pharmaceutical company located in Hunt Valley, MD.

The Principal Scientist will be responsible for the formulation and process development of oral dosage products. In addition, you will independently research and introduce new formulation technology for bioavailability enhancement and will work with client for formulation strategy and troubleshooting.

Must be eligible to work in the US.

Job Responsibilities:

• Design and execute formulation trials and evaluate stability data to finalize formulation composition in one or more techniques described above.
• Develop manufacturing processes for R&D formulations so that the technical transfer is successful for large scale batches.
• Coordinate sourcing of APIs, excipients, packaging components for new products to meet regulatory requirements.
• Write/review master formulas, manufacturing procedures, review stability protocols/reports, process validation protocols/reports, Technology Transfer Reports (TTD's), Product Development Reports (PDR's), memoranda and all other department-related documentation.
• Establish raw material (API and Excipients) characterization, review specifications for drug products and packaging components to help control and produce a robust formulation.
• Coordinate the manufacturing of exhibit/submission batches per regulatory requirements.
• Perform technology transfer for manufacturing processes from laboratory scale to production scale.
• Coordinate with Analytical Method Development, Regulatory Affairs, Quality Control, Quality Assurance to expedite the development and approval of new products by FDA.
• Provide technical support during process validation and cleaning validation studies.
• Utilized QBD approach for formulation development with experience in DoE and statistical analysis of data.
• Assure that all formulation and process development activities are documented in the notebook as per procedures and cGMPs/cGLPs.
• Independently design and execute formulation experiments. All activities must follow cGMP's procedures and corporate polices.
• Design and recommend the purchase of equipment as per project requirements.
• Demonstrate good planning and organization skills to track quality issues for multiple components and multiple component vendors. Demonstrates the ability to prioritize activities to ensure timely release of components to support production.
• Must check equipment before starting a project to ensure it runs smoothly and right the first time.
• Communicate the project progress with Supervisor, Client and Management through oral and written updates and formal reports as necessary.
• Support the business aspects of their position by taking responsibility for the execution and billing communication for all work proposals under their supervision.
• Participate in BD and marketing activities to bring new business by generating scientific expert content, presenting R&D capabilities and providing solution to client requirements.

Skills and Requirements:

• PhD in Pharmaceutical Sciences with 5 - 7 years' experience, MS in Pharmaceutical Sciences with 7-10 years' experience, BS in Scientific Discipline with 10-12 years' experience, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills and abilities.
• Have sound Pharmaceutics Know-How to analyze and interpret data and regulatory requirements.
• Should have excellent planning, project management, verbal and written skills.
• Must have a minimum of one year of relevant experience working at a CDMO
• A background and thorough knowledge of cGMP's compliance and other regulatory requirements, i.e., FDA, DEA, etc., within the pharmaceutical industry.
• Ability to write and understand technical information and produce detailed reports.
• Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.
• Ability to analyze data/information and to assess and resolve complex problems/issues, as required.
• Demonstrates the ability to work independently and on teams.
• Must have experience writing, reviewing and maintaining cGMP and cGLP documents i.e., Laboratory Notebooks, Batch Records.
• Ability to effectively train other individuals on cGMP's, Policies, and Procedures.
• Must be able to comprehend and follow all applicable SOPs
• Knowledge / Experience with electronic Quality Management Systems such as MasterControl
• Knowledge of current federal, local, and international regulations regarding the production, testing and release of drug substances and products.
• Must have strong computer skills and be proficient in office and statistical software like MS Word, Excel, Access, Power Point, Minitab/JMP, etc.
• Ability to always portray an appropriate level of integrity and professionalism.
• Ability to communicate effectively with management, staff, regulators, and client representatives, in both written and verbal forms.
• Ability to complete tasks accurately and according to established timelines.
• Ability to make sound decisions about scheduling, allocation of resources and managing priorities.
• Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
• Results oriented and efficient.
• Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
• Ability to work closely with a diverse customer and employee base (internally and externally).
• Ability to work well in a cross-functional team environment.
• Must communicate fluently in English and have legible handwriting.
• Ability to travel between and within facilities to visit staff, operations, and projects, as needed.
• Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).
• Ability to lift up to 40 pounds on occasion.
• Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).

If you are having difficulty in applying or if you have any questions, please contact Jessika Rodriguez at +(1) 617-391-0929 or j.rodriguez@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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