Kilo Chemist III

Veranova L P • Devens, MA

3d • Onsite

About The Position

Under the direction of a Production Supervisor, the Kilo Chemist III manufactures active pharmaceutical ingredients (APIs) in support of the business unit while meeting applicable quality and safety regulations. The role is based 100% onsite at Veranova’s Devens, Massachusetts facility and requires working a rotating schedule covering first, second, and third shifts.

The position performs complex batch processing and unit operations, operates and adjusts manufacturing equipment, supports troubleshooting and production planning, and maintains compliance with FDA and current Good Manufacturing Practices (cGMP). The Kilo Chemist III also supports safety, environmental, audit-readiness, emergency-response, and training activities, and coaches less experienced workers.

Veranova is a global developer and manufacturer of complex APIs for pharmaceutical and biotechnology customers. The company describes its work as supporting innovation and enabling current and next-generation therapeutics.

Requirements

• Associate degree in Chemistry, Engineering, or another related technical field and at least 6 years of experience in a regulated manufacturing facility; alternatively, a bachelor’s degree in one of these fields and at least 5 years of experience in a regulated manufacturing facility.
• Must be open to working rotating first, second, and third shifts.
• Must be able to stand, walk, use hands to operate objects, tools, or controls, reach with hands or arms, and climb, balance, stoop, kneel, or crouch as needed for job activities.
• Must be able to lift 50 pounds and occasionally lift or move more than 100 pounds using available material-handling equipment.
• Must be authorized to work in the United States without further employer sponsorship.

Responsibilities

• Complete batch records in accordance with FDA and cGMP guidelines and maintain the facility in an excellent FDA/cGMP position.
• Apply cGMP standards and provide process support and troubleshooting to meet customer requirements.
• Maintain appropriate housekeeping and 5S areas.
• Use required safety equipment and participate in the safety program and hazard analysis; wear appropriate PPE for each task.
• Ensure the security and safe handling of controlled substances and comply with Company and DEA regulations.
• Characterize, label, store, and dispose of waste in accordance with Company, state, and federal regulations; collaborate with Environmental, Health & Safety as appropriate.
• Ensure production and support equipment is in proper operating condition and has current documentation; collaborate with Maintenance as appropriate.
• Serve as an active member of the Emergency Response Team and participate in related training and activities.
• Cooperate with root-cause investigations, follow corrective actions, and comply with Company policies and applicable regulations.
• Contribute to audit readiness and participate in EH&S audits with internal Company groups, regulatory agencies, and customers.
• Report near misses, accidents, and dangerous occurrences through Company procedures so investigations can be initiated.
• Communicate effectively with the QC Testing group about timing and prioritization of in-process samples.
• Set up and operate machines and equipment, adjusting temperature, pressure, flow, reactions, or materials safely and according to batch records and work instructions.
• Perform complex batch processing and unit operations, including hydrogenations and PFD operations.
• Resolve routine technical problems and take action to keep the production plan moving.
• Coach, mentor, and train less experienced workers on basic tasks and participate in peer-to-peer training in unit operations.

Benefits

• Comprehensive health and wellness benefits.
• Access to mental health resources and wellness programs.
• Generous paid time off and holiday pay policies.
• Eligibility for an annual incentive bonus program for full-time employees; bonus targets vary by career level and depend on individual and company performance.
• 401(k) plan with company match.
• Continuous learning opportunities through LinkedIn Learning, workshops, conferences, and mentorship.
• Tuition assistance for undergraduate and graduate degree programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Associate degree