Senior Clinical Manufacturing Lead II

AbbVie Inc.; Chicago (IL); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Paid time off

Medical/Dental/Vision insurance

401(k)

Short-term incentive program

Job summary

AbbVie Inc. in Chicago, IL seeks a Senior Production Lead to oversee solid dosage form clinical supplies, leading manufacturing activities and ensuring GMP-compliant processes.

You will collaborate with formulation development in the pilot plant, manage batch records, and coordinate with QA to ensure timely product delivery. A strong cGMP background and 10+ years in operations/R&D are required.

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.

Responsibilities

• 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.
• Collaborates with formulators on formulation development and pilot plant activities.
• Provides technical guidance to manufacturing personnel and leads troubleshooting.

Skills

Leadership

Manufacturing

Quality documentation

Project coordination

Education

B.S. in Chemistry or Biology

Tools

Pilot plant equipment

Job description

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

• 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 any other 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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html