22 days old

Production Manager

Sebela Pharmaceuticals Inc.
Holbrook, MA 02343
Sebela Pharmaceuticals is looking to add a talented Production Manager 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.



 
 


PRINCIPAL DUTIES AND RESPONSIBILITIES


 




  • The ability direct manufacturing efforts and meet the directives and goals established by the VP of Manufacturing Operations. Communicates issues and results to the VP.



  • In conjunction with the safety committee, manage plant safety to comply with OSHA requirements. Monitor manufacturing plant safety to regulations, establish and implement safety measures as needed, and train staff on applicable safety procedures.



  • Develop operational excellence and continuous improvement paradigms through quality systems.



  • Work cross functionally with Quality Assurance to establish and perform corrective actions.



  • Troubleshoot manufacturing issues to maintain the quality of the product and maximize efficiency.



  • Establish resolutions for manufacturing; manage the resolutions with Quality Assurance, and implement corrective actions (CAPA management).



  • Perform or assign batch record revisions and deviation resolution. Verify or complete cGMP documentation and batch records accurately.



  • Monitor and/or perform training of manufacturing staff and completion of training modules.



  • Ensure manufacturing efficiencies through proper scheduling and planning.Ensures the delegation of staging of material and personnel, and proper logistics.



  • Manage the requisition of materials, movement of inventory, and account for inventory. Coordinate material with materials management and purchasing.



  • Ensure and/or verify equipment runs to meet product specifications. Write or update SOPs and batch records to ensure proper operating procedures.



  • Monitor the equipment performance during packaging or manufacturing and perform inspections as needed.



  • Perform start up documentation for packaging and manufacturing of product and perform control checks (if applicable).



  • Verify the cleaning and proper maintenance of equipment and rooms, managing progress with the maintenance staff.



  • Write deviations, determine root causes for issues and develop sound corrective actions.


    Write and execute Installation Qualifications, Operational Qualifications, Performance Qualifications, Cleaning Validation and Process Validation documentation.


     




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 Pharmaceutical Manufacturing. The requirements listed below are representative of the knowledge, skills and/or abilities required.


 




  • Bachelor degree with 2-5 years experience and/or Associates Degreeand 5-7 years supervisory experience in a manufacturing environment and /or high school diploma or technical school and ten plus years of incremental supervisory experience in a pharmaceutical/biotechnology manufacturing environment.





  • 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 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: 2020-11-07 Expires: 2020-12-07

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Production Manager

Sebela Pharmaceuticals Inc.
Holbrook, MA 02343

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast