Product Development Formulation Chemist

Job Description

 

 

 

Title: Product Development Formulation Chemist

 

Division: Technical Operations

 

Department: Product Development

 

Reports to: Manager of Product Development

 

 

Individual Responsibilities:

 

Responsible for formulation activities related to ANDA submission products including; pre-formulation studies, compatibility studies, filter validation, and manufacture of lab or demo batches.

Responsible for de-formulation of innovator product including container/closure system, ingredients, manufacturing steps and precautions, storage conditions, etc.

Responsible for transfer of compounding and manufacturing technology to CMO including drafting of batch record and identification/procurment of specific manufacturing equipment necessary.

Responsible for ensuring completion of validation activities at CMO relating to component preparation, compounding, filling, and sterilization of products.  

Responsible for identification and evaluation of API, excipient and component sources and will initiate Vendor Qualification as necessary. 

Assist in the compilation of internal and external documentation and data in support of ANDA Submissions, including writing or reviewing reports, summaries and technical justifications. 

Provide technical review of all documents relating to batch manufacture, validation, SOPs, protocols, reports and submission documents.

Act as liaison for CMO to ensure successful transfer and manufacture of ANDA products.

Provide technical support for on-going commercial production, as necessary.

Other duties as assigned.

 

 

 

Qualifications:

 

Must have a BS/MS in Chemistry, Biology, Biochemistry, Pharmacy or other related scientific/engineering field. 

Minimum of 7 years of relevant, hands-on pharmaceutical industry experience in product development and formulation functions

Experience with parenteral drugs and oncology drugs preferred.

Thorough understanding of cGMP procedures, FDA requirements for analytical labs, manufacturing and FDA Submissions.  Previous ANDA Submission experience is preferred.

Familiar with typical pharmaceutical manufacturing operations and equipment including component preparation, compounding, filling and sterilization.

Demonstrated ability to work independently and within a team setting, conduct literature searches, implement published methods, provide support to teammates and assist in preparation of scientific documents.

Must have strong oral and written communication skills, as well as good technical problem-solving, organizational and project planning skills.

Must be proficient on computer software programs including MS Office, Excel, Access and data acquisition.

Highly motivated, task oriented with ability to adapt to changing priorities.