Less than 1 hour

Manufacturing Specialist

Sebela Pharmaceuticals Inc.
Holbrook, MA 02343


Sebela Pharmaceuticals is looking to add a talented Manufacturing Specialist to our team in Holbrook, MA.


 


What do we offer?



  • Competitive salary

  • Outstanding benefit package

  • Paid Time Off

  • 401(k) with a generous company match.




SUMMARY


The Manufacturing Specialist is responsible for performing the necessary activities required to support the Holbrook sites project and administrative functions in compliance with current industry and regulatory expectations. Supports administrative efforts for both research products and drug product as an OEM drug manufacturer. Supports all aspects materials management. Supports documentation, project and commercial product launch efforts.  Will perform tasks associated with metrics and reporting. 


 


 


PRINCIPAL DUTIES AND RESPONSIBILITIES


 



  • Support project planning, task management, work plan development and execution in support of projects, new product development, and commercial launches

  • Support timelines for specific strategic projects for management

  • Support the communication of and conformance with the Production Schedule based on inventories and sales

  • Support Budgeting, Costing and Accounting Activities

  • Perform Administrative and Clerical Tasks such as creating and editing documents, analysis of data, and batch record/documentation review

  • Support implementation of change controls and corrective actions for investigations, CAPAs and audits

  • Produce Metrics, Meeting Agendas and Minutes, Reporting Activities and Project Status Reviews

  • Supports Materials Inventory and Logistical Management

  • Support implementation of process efficiency improvements

  • Support employee training

  • Create and execute Equipment Qualification Protocols (IQ/OQ/PQ), Cleaning and Process Validation protocols and Computerized Systems validation protocols.

  • Responsible for the development of documentation to support computer validation such as User/Functional Requirements specifications, Design Specifications and Risk Assessments

  • Perform batch record and SOP revisions.

  • Draft Incident and Deviation reports.

  • Complete cGMP documentation and validation protocols accurately.



 


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 product lifecycle management. The requirements listed below are representative of the knowledge, skills and/or abilities required. 



  • Bachelors degree and 2-5 years relevant project management experience in an FDA regulated industry or an equivalent amount of 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

  • Verbal and written communication skills. Must be able to read, write, and converse in English.



 


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 or stand for long periods of time. The employee is occasionally required to walk, stoop, kneel, crouch, or crawl.


 


ABOUT BRAINTREE, A PART OF SEBELA PHARMACEUTICALS


 


Braintree is the GI division of Sebela Pharmaceuticals, a leading specialty pharmaceutical company focused on three core therapeutic areas: gastroenterology, dermatology and womens health.  As part of Sebela, Braintree is a market leader in GI, including the #1 prescribed, branded bowel prep product, SUPREP and five marketed GI products as well as a rich near-term GI pipeline of products for diarrhea, constipation, and next generation colonoscopy preps providing multiple product launches over the next three to four years.


 


Sebelas growth is fueled through acquisitions, targeted promotion and judicious investment in infrastructure.  As a result of our business model, our culture is characterized by a high degree of urgency, open dialogue and discussion across all levels of the team, willingness to challenge the traditional approach, and shared ownership of the organization were building and our results.  We operate with a lean approach, focusing on investments that drive the growth of our business.  We are all willing to step in and do whatever is needed on any given day, regardless of the title we hold. Sebela offers a competitive compensation package including base salary, bonus based on personal and company performance, options (both upon hiring and potential in future years based on performance), and a comprehensive health benefits package.

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Posted: 2020-12-02 Expires: 2021-01-01

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Manufacturing Specialist

Sebela Pharmaceuticals Inc.
Holbrook, MA 02343

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