Chemical Operator

POSITION SUMMARY: Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility, located in Riverview, Michigan, is seeking a qualified Chemical Operator II to join our Production team. The Chemical Operator II is responsible for 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.

• Conduct chemical syntheses of APIs and their intermediates within scheduled dates or times independently.
• 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.
• Maintain, operate and troubleshoot process-specific utilities independently.
• Control the inventory of basic raw materials, consumables, and wastes within the immediate working environment.
• Document all work conducted according to ASI required format(s). Including but not limited to electronic systems.
• Recognize and report documentation issues to supervision and QA.
• Assist in the assembly and maintenance of documents particular to the operation and complying with applicable regulatory requirements.
• Assist supervision in support of the facility by:
• Recognizing and reporting equipment issues to Supervisor and Maintenance.
• Recognizing and reporting inventory issued to Supervisor and Purchasing.
• Support site waste management.
• Reviewing and generating supporting SOPs

EDUCATION/EXPERIENCE.

• High school diploma or equivalent.
• Two (2) year diploma from an accredited institution or equivalent experience strongly preferred.
• Two (2) years minimum experience as Chemical Operator I or equivalent experience in a chemical manufacturing environment.
• Must have GMP and Batch Record experience.
• Pharmaceutical Manufacturing preferred.

JOB COMPETENCIES.

• Mechanical skills in assembly and use of bay processing equipment and aides, as well as troubleshooting skills for all equipment.
• Good understanding of application software systems including but not limited to Trackwise, SAP, MasterControl.
• Ability to interact effectively within all levels of the company.
• Self-starter with the ability to recognize tasks that need to be completed and to adjust schedules in order to meet commitments.
• Excellent record-keeping and communication skills.
• Knowledge of job-related regulatory requirements (cGMP, OSHA, and EPA).
• Must be able to pass a respirator fit test.

ABOUT US

PPS-Riverview is a full-service pharmaceutical contract manufacturer (CMO) offering comprehensive small-molecule drug substance development and cGMP manufacturing services of active pharmaceutical ingredients (APIs). With over five decades of experience, PPS-Riverview is committed to providing the highest quality of service and delivering on time, and on budget.

PPS-Riverview has extensive experience developing and manufacturing APIs for Life Science companies developing innovator small-molecule therapeutics. PPS-Riverview is a long-time provider of contract research services to the National Institutes of Health and the National Cancer Institute, and has participated in the development of many important drugs through these government agencies. To date, PPS-Riverview has received fourteen FDA manufacturing approvals for innovator APIs, including a number of fast-track manufacturing approvals for the active ingredients for the oncology drugs Velcade®, Vidaza®, Clolar® and Iclusig®.

Services offered by PPS-Riverview include process development and scale-up; cGMP manufacturing; development and cGMP manufacture of highly potent APIs using barrier-isolation technology; comprehensive analytical capabilities (including method development, stability studies and qualification of reference standards); and regulatory support for all phases of drug development and manufacturing.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Referral program
• Relocation assistance
• Retirement plan
• Tuition reimbursement
• Vision insurance

Work Location: In person