Chemical Process Engineer Group Leader

About the position

CordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients, and pharmaceuticals Drug Products (DP) and packaging capabilities with > 2,600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people's lives. The position provides strong, technical leadership and documentation in the areas of process development, process improvement, troubleshooting, optimization, and manufacturing process support in assigned group or plant. Ensures the reliability, accuracy, and cGMP compliance of documents for production, validation, qualification, etc. and supports and troubleshoots investigations when required. Interacts with management in developing project objectives, department goals and site concepts & strategies; advises management regarding technical opportunities and advances.

Responsibilities

• Provides leadership and oversight for process engineers in the group.
• Evaluates new process fits into manufacturing, considering safety factors, cost, equipment, chemistry, and unit operations for both new products and commercial products.
• Performs process development via process modeling or testing at lab scale, concentrating on key scale up parameters.
• Develops and implements innovative process scale-up technologies that significantly improve our business' ability to meet customer needs and business performance.
• Identifies, evaluates, develops, and implements process improvements and optimization that reduces costs, improves yield/cycle time/quality, addresses EHS impacts, reduces downtime, and improves process consistency/robustness.
• Supports Manufacturing by authoring process flow diagrams (PFD), providing technical information that serves as basis for batch records and drafting batch records.
• Provides process training/training packages for operations and other support groups.
• Authors deviation investigations and campaign summary reports.
• Supports process validation by providing technical requirements for validation protocols and addressing validation deviations from a technical perspective.
• Provides on-floor support to Manufacturing as needed: oversight of implementation of new processes or startup of commercial processes, troubleshooting of process and equipment issues.
• Generates commercial scale fits and COGs estimates.
• Provides process technical input for capital projects that support commercial scale production needs.
• Participates in setting production standards for commercial processes.
• Authors technical documents/reports in support of regulatory filings.
• Serves as 'Technical Team Lead' on broad, complex projects and responsible for directing the interdisciplinary technical teams' efforts.
• Provides updates (formal and informal) to Project Management and LT, as needed, regarding project progress, issues/issue resolution, and results.
• Develops and implements innovative process scale-up technologies.

Requirements

• A BS in Chemical Engineering.
• 10 years' experience of demonstrated success in Process Engineering in a Pharmaceutical or Fine Chemicals Manufacturing environment.
• Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
• Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
• Ability to write speeches and articles for publication that conform to prescribed style and format.
• Ability to effectively present information to top management, public groups, and/or boards of directors.
• Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.

Benefits

• 401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service.
• Accident Plan.
• Critical Illness Insurance.
• Dental Insurance.
• Disability Insurance.
• Employee Assistance Program.
• Flexible Spending Account.
• Health Insurance PPO/HSA.
• Hospital Indemnity Plan.
• ID Theft Protection.
• Life Insurance.
• Paid Maternity/Paternity Leave.
• Tuition Reimbursement.
• Wellness Program.
• Vacation - Three Weeks 1st Year.
• Vision Insurance.