Process Lead

  • Piramal Pharma Solutions (Riverview)
  • Riverview, MI, USA
  • Jul 15, 2019
Full time Biotech

Job Description

Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility (Ash Stevens, LLC), located in Riverview, Michigan, is seeking a qualified Process Lead to join our Production team. The Process Lead is responsible for coordinating production activities of shift and/or team, including assigning tasks and training employees.  The incumbent will also assist in conducting chemical syntheses/manufacture of active pharmaceutical ingredients (APIs), their intermediates and other materials according to applicable SOPs, batch records, and current Good Manufacturing Practices (cGMP).

 

To perform this position successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill and/or ability required:

 

  • Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices.
  • Consistent support and practice of all Piramal Pharma Solutions mission, vision, and values.
  • Identify and protect the original technical information as part of the company property.

 

 

Key Responsibilities.

  • Provide daily direction to Chemical Operators of team regarding manufacturing, cleaning, and associated activities.
  • Lead, mentor and train all Operators.
  • Control inventory of basic raw materials, consumables, and wastes within the working environment and coordinate requirements of raw materials with Purchasing.
  • Conduct chemical syntheses of APIs and their intermediates within scheduled dates or times.
  • Provide feedback to supervision and tech transfer concerning prospective process routes and/or synthetic procedures.
  • Comply with all applicable policies and procedures. This includes those required by PPS as well as external regulatory bodies.
  • Maintain cleanliness and routine maintenance of the work area and equipment items within the working environment.
  • Document all work conducted according to PPS required format(s).
  • Assist in the assembly and maintenance of documents particular to the operation and complying with applicable regulatory requirements.
  • Determine need for and then create and revise unit documentation as required (SOP's, Batch Records, Cleaning Documents).
  • Recognize and report needs, concerns, and/or problems to supervision in a timely manner.
  • Assist Environmental, Health, and Safety in maintenance and coordination of site Waste Management Plans, including packaging, labeling, manifesting, and shipping. Also assists in monitoring site pollution control programs and compliance with site safety regulations.
  • Use electronic systems as designated by PPS.

 

EDUCATION/EXPERIENCE.

  • High school diploma or equivalent.
    • Two (2) year diploma from an accredited institution or equivalent experience strongly preferred.
  • Three (3) years minimum experience as a Chemical Operator III and/or combination of five (5) years’ experience in a chemical laboratory or batch manufacturing environment with supervisory experience.
  • Prior industrial chemical experience highly preferred with emphasis on FDA regulated environment.

 

job competencies.

  • Ability to fill in for the Production Supervisor in their absence.
  • Mechanical skills in assembly and use of bay processing equipment and aides, as well as troubleshooting skills for all equipment.
  • Full, independent user of applicable software systems, including but not limited to: Trackwise, SAP, MasterControl.
  • Ability to interact effectively within all levels of the company.
  • Demonstrated self-starter with ability to adjust schedules in order to meet commitments.
  • Excellent record-keeping and communication skills.
  • General knowledge of regulatory requirements and quality systems (cGMP, OSHA, and EPA).
  • Must be able to pass a respirator fit test.

 

Job Conditions.

 

The physical demands and work environment described here are representative of those that must be met by a team member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

  • Physical Demands:
    • Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected.
    • Long periods of standing and walking can be expected in this position.
    • This position may require long periods of sitting, typing, computer entry or looking at a computer.

 

  • Work Environment:
    • Piramal Pharma Solutions is engaged in the business of pharmaceutical research and contract pharmaceutical manufacturing. As such, all PPS staff work in or nearby either chemical/pharmaceutical research or chemical/pharmaceutical manufacturing equipment and processes.
    • Potential limited exposure to hazardous chemicals.
    • Personal protective equipment including safety glasses, lab coats, gloves, specialized clothing including laboratory uniform and appropriate shoes may be required in areas associated with this position.