GMP Process Implementation Specialist — Drive Change

CordenPharma; Boulder (CO); On-site; USD 80,000 - 90,000; Full time

Benefits offered by this job

401(k) matching

Health Insurance PPO/HSA

Tuition Reimbursement

Job summary

CordenPharma in Boulder, CO is seeking a Process Implementation Specialist to lead and coordinate manufacturing process roll-outs. You will work across Manufacturing, R&D, regulatory, and CPC customers to ensure timely startup activities and compliant change control.

Ideal candidates will have a BS degree with GMP experience and strong leadership and communication skills to drive project implementations in a fast-paced environment.

Qualifications

• Bachelor’s degree (BS) from a 4-year college; or 5 years related experience in Chemical or Pharmaceutical Manufacturing (GMP preferred) and/or training; or equivalent.
• Strong communication and leadership skills; ability to manage cross-functional teams.

Responsibilities

• Establishes and maintains strong relationships between Manufacturing, R&D, internal support, regulatory groups, and CPC customers.
• Executes startup activities for chemical processes to ensure schedule adherence.
• Generates change control documents and reviews, updates drawings and P&IDs, and completes change control closure.
• Works with Maintenance and Operations to schedule and complete activities.
• Represents Manufacturing in project design and ensures EH&S and budget requirements are met.

Skills

Leadership

Communication

Problem solving

LEAN

Education

Bachelor's degree (BS)

Job description

CordenPharma in Boulder, CO is seeking a Process Implementation Specialist to lead and coordinate manufacturing process roll-outs. You will work across Manufacturing, R&D, regulatory, and CPC customers to ensure timely startup activities and compliant change control.

Ideal candidates will have a BS degree with GMP experience and strong leadership and communication skills to drive project implementations in a fast-paced environment.