Senior Clinical Manufacturing Lead II

AbbVie; North Chicago (IL); On-site; USD 97,000 - 184,000; Full time

Job summary

AbbVie in United States (North Chicago) seeks a senior leader to oversee production teams for solid dosage form clinical supplies, ensuring GMP-compliant processes and timely manufacturing using state-of-the-art technologies.

The role requires guiding formulation development, providing technical manufacturing guidance, and coordinating with QA, CMC, and other groups to meet project goals while maintaining high quality and compliance.

Qualifications

• B.S. in Chemistry, Biology or related scientific area or equivalent with relevant experience.
• 10+ years experience in operations, R&D and/or related area.
• Experience in a cGMP environment is highly desired.

Responsibilities

• Leads manufacturing activities, including preparation and close out of batch records; ensures the batch record documentation is executed with minimal errors; starts and completes manufacturing activities on time, according to the established schedule.
• May supervise the pilot plant technicians including daily scheduling of activities, managing personnel development, holding technicians accountable against performance expectations, and writing and delivering performance reviews.
• Collaborates with formulators on formulation development and research activities occurring in the pilot plant.
• Provides detailed knowledge of pilot plant equipment and processing capabilities; provides technical guidance to manufacturing personnel; participates in optimization initiatives.
• Understands and follows cGMP requirements, established policies; writes and follows procedures; follows safety requirements.
• Works with the CMC team to assure project commitments; provides draft batch records for review; ensures material availability and inventory transactions.
• Records, tabulates and reports results; communicates significant issues to management; participates in group meetings.
• Directs activities of manufacturing technicians in a matrix environment.

Education

B.S. in Chemistry, Biology or related scientific area or equivalent

Job description

• Compensation: USD 96,500 - USD 183,500 - yearly

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

Job Description

Lead production teams to produce high quality solid dosage form clinical supplies utilizing state-of-the-art technologies. This requires interaction with formulation colleagues to develop reliable and efficient manufacturing processes. These processes are then translated into executable manufacturing instructions when followed appropriately result in the efficient production of GMP compliant clinical supplies.

• Operations: Leads manufacturing activities, including the preparation and close out of batch records; Ensures the batch record documentation is executed with minimal errors; Starts and completes manufacturing activities on time, according to the established schedule. Leads discussions with QA on quality related topics associated with manufacturing and documentation. Manages X-step content to ensure PI sheets are accurate.
• Supervision: May supervise the pilot plant technicians including daily scheduling of activities, managing personnel development, holding technicians accountable against performance expectations, and writing and delivering performance reviews. May provide similar supervision to Clinical Manufacturing Lead I and/or II.
• Formulation Development: Collaborates with formulators on formulation development and research activities occurring in the pilot plant. Provides key pilot plant capabilities insight on these activities.
• Technical Support: Possess detailed knowledge of pilot plant equipment and processing capabilities. Provide technical guidance to manufacturing personnel. Provides leadership with trouble-shooting and identifies solutions to issues that arise during manufacturing; Provides strategic product development and technology improvement activities; actively participates in functional area improvement initiatives.
• Compliance: Understands and follows cGMP requirements, established policies; Writes and follows procedures and practices; Conducts business activities needing minimal deviations or exceptions; Follows established safety requirements, reports incidents/near misses and recommends improvements.
• Project Coordination: Works with the CMC team and other supporting areas to assure project commitments are met, for example, providing draft batch records for review, assuring material availability, preparing cleaning documentation and completing inventory transactions.
• Communication: Records, tabulates and reports results within the group or team using the necessary tools (Reports, memos, presentations, spreadsheets, notebooks, etc.); Reports significant issues to management with appropriate sense of urgency; Attends group and project meetings, being prepared to communicates concerns and participate in discussions.
• Leadership: Direct activities of manufacturing technicians in a matrix environment.

Qualifications

• B.S. in Chemistry, Biology or related scientific area or equivalent and relative work experience.
• 10+ years experience in operations, R&D and/or related area
• Experience in a cGMP environment is highly desired

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or anyother form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company'ssoleandabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.