Less than 1 hour

Manager Formulation and Clinical Manufacturing

Sebela Pharmaceuticals Inc.
Holbrook, MA 02343

Sebela Pharmaceuticals is looking to add a talented Production Line Mechanic to our team in Holbrook, MA.


 


What do we offer?



  • Competitive salary

  • Outstanding benefit package with a substantial employer contribution (Medical, Dental, Vision, STD, LTD, Life Insurance)

  • Paid Time Off

  • 401(k) with a generous company match.



SUMMARY


The Senior Manager Formulation and Clinical Manufacturing is responsible for activities related to new product and process development, including manufacturing, packaging and labeling of new products in the development pipeline for Clinical Trials.  Evaluates improvements to existing processes and troubleshoots problems. Assists with design and procurement of new equipment and technology transfer from R&D to clinical and commercial manufacturing. Plans workflow and work force utilization. Manages employee morale in conjunction with Human Resources and the VP of Manufacturing Operations.


 


PRINCIPAL DUTIES AND RESPONSIBILITIES



  • Development of formulations and processes for new and existing products.

    • Dry Blending

    • Tablets, capsules

    • Tablet Coating

    • Liquids



  • Preparation of development reports and other technical documentation to support the IND and NDA processes.

  • Preparation of protocol documentation for the manufacture of development and clinical batches.

  • Process Design and Technology transfer activities, including equipment design, process scale up, and development of batch records and other documentation.

  • Establishes equipment and process parameters that may impact the quality of drug products.

  • Involved in the procurement of equipment and supplies required for clinical and FDA exhibit lots.

  • Ensures cGMP requirements are met as they relate to development of new products and the manufacture of clinical and submission materials.



QUALIFICATIONS


 


To perform this job successfully, an individual must be able to perform each essential function satisfactorily, be flexible in terms of work hours, and have strong knowledge and experience in Process Engineering and Clinical Manufacturing. The requirements listed below are representative of the knowledge, skills and/or abilities required.



  • Bachelor Degree or higher in Engineering and 2-5 years relevant supervisory experience in an FDA regulated industry with Product Formulation, Clinical Manufacturing, Process Engineering experience, or a Bachelor Degree Life Sciences or related discipline and 5-7 years relevant supervisory experience or an equivalent amount of Process Engineering/Product Formulation experience in pharmaceuticals/biotechnology.

  • Exceptional technical writing, review and analytical skills.

  • Knowledge of good documentation practices and cGMPs.

  • Must have strong ability to organize and manage multiple tasks in a fast-paced environment

  • Excellent verbal and written communication skills.



WORK ENVIRONMENT


 


The work environment described here are representative of those an employee encounters while performing the essential function of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This position will be in an office and Manufacturing environment.


 


PHYSICAL REQUIREMENTS


 


The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this Job, the employee is regularly required to sit for long periods of time. The employee is occasionally required to stand, walk, stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.

Categories

Posted: 2020-10-20 Expires: 2020-11-19

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Manager Formulation and Clinical Manufacturing

Sebela Pharmaceuticals Inc.
Holbrook, MA 02343

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