Position Objective:

Assist in planning, designing and execution of analytical method development experiments. Participate in pre-formulation, formulation and manufacturing process development experimentation. Work largely independently and with minimum supervision to execute experiments and report results in a timely and organized manner. Assist in coordinating analytical development and testing activities at CROs and provide support to formulation and process development, and manufacturing activities at CMOs as needed. May provide analytical services to the team managing commercial product supply. May assist with support the oversight of analytical development, method validation, and method transfer to CROs and/or assisting in preparing CMC sections and supporting documents for regulatory submissions.

Essential Functions:

Assist in planning and designing, and execute experiments to develop analytical methods. Contribute analytical testing to pre-formulation, and process development formulation matrix/drug delivery system using various analytical techniques, such as HPLC, dissolution/drug release USP apparatus, spectroscopic techniques, etc.

Prepare technical reports, quantitative analyses, SOP’s/protocols and other on-going documentation and summaries of findings.   Maintain current laboratory notebooks and/or computer files and assist in administering safety policies and procedures.
 

Present data at internal meetings and certain external scientific conferences and meetings when requested. 

Participate in the development of data utilized in the completion of regulatory filings, research grants and/or patent applications.

Maintain a thorough knowledge of the theories and techniques of an experienced Associate Scientist in the Analytical Development field and share knowledge with peers and others.

May perform other related duties as required and/or assigned.

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:

MSc/BSc in Chemistry, Pharmaceutical Sciences, Chemical Engineering or equivalent education and experience.

Experience: 

Minimum of 3 years of experience in biotech/pharmaceutical industry. Solid hands-on experience with analytical/process development; formulations background and exposure to commercial product supply and manufacturing a plus. Experience with operation and basic maintenance of common analytical instruments (e.g., HPLC, Particle Size Analyzer) and office software strongly preferred. Experience with GMP/GLP requirements. Ability to operate successfully in a team environment. Solid communication and organizational skills.

Working Conditions:

Works in a laboratory, facilities and/or manufacturing environment.  May on a continuous basis walk, bend and lift up to 30 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 local 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