Senior Scientist, Product Development

Position Objective:

Execute formulation development work to support new products, develop drug product manufacturing processes, work with CMOs to manufacture drug products to support clinical development programs.

Essential Functions:

• Perform formulation development for new drug candidates, design product manufacturing processes.

• Supply formulated product for research, biological, and tox studies

• Work with CMOs to manufacturing products to support clinical programs. Transfer manufacturing processes to the CMO, review manufacturing batch records and other manufacturing documents.

• Oversee detailed technical requirements, resource requirements, timelines and decision points in a manner consistent with the Company’s mission and priorities. 

• Prepare and/or oversee the preparation of the CMC section(s) of IND submissions and other filings as needed.

• Interact closely with counterparts in Research, Quality Assurance, Regulatory and Project Management, and participate in regular project and CMC review meetings to ensure effective communication and sharing of information. 

• May perform other related duties as required and/or assigned, including providing advice and technical support to the broader Operations department.

Nature and Scope:

Interacts with various levels of personnel internally, and typically a similar level externally requiring the ability to clearly understand and communicate policies and procedures.  Requires a solid working knowledge relevant to the applicable field.   Job encounters problems of limited scope and moderate complexity with occasional variations from the norm. The incumbent receives instruction on new assignments and limited instruction on routine work.  Errors in work could cause delays and financial loss.

Education:

MS degree in Pharmaceutical Sciences, Analytical Chemistry, or a related discipline required. PhD preferred.

Experience:

• 3-8 years’ experience in formulation development and/or drug product manufacturing

• 3-5 years’ experience working with contract manufacturing facilities in managing manufacturing projects to mean companies requirement and timelines.

• In-depth scientific knowledge and hands-on experience in formulation development and/or product manufacturing

• Knowledge of GMPs and regulatory requirements as related to formulation development and drug product manufacturing

• Experience in analytical method development and /or analytical testing is desirable

• Previous supervisory experience a plus.

Working Conditions: 

Works in an office and laboratory environment. May on a continuous basis walk, bend and lift up to 40 lbs.  The noise level in the work environment is usually moderate to high.  May intermittently sit at desk for a long period of time to answer telephone and write or use a keyboard to communicate through written means.  Must be flexible to work varying schedules and hours as needed.  Occasional travel may be required.  The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Equal Opportunity Employer/Females/Minorities/Veterans/Disability