Sr. Manager, Manufacturing Sciences & Technology

Pharmaceutical Compliance Forum Inc; Cary, Northern (NC, KY); Hybrid; USD 160,000 - 175,000; Full time

Job summary

Pharmaceutical Compliance Forum Inc in Cary, NC seeks a Senior Manager, Manufacturing Sciences & Technology (MS&T) to lead the manufacturing science strategy for a high-volume commercial small molecule program, including coating and dissolution-focused process robustness.

You will own PPQ studies, CPV collection, change controls, and regulatory submissions, while mentoring engineers and coordinating with CDMO partners to sustain a busy manufacturing calendar.

Qualifications

• 10+ years pharmaceutical/biotech manufacturing experience.
• Experience with film-coated, modified-release solid dosage forms and dissolution testing.
• Experience supporting a high-volume commercial manufacturing program and regulatory submissions.
• Mentor and develop junior technical staff in a global network.

Responsibilities

• Lead MS&T product lifecycle for a high-volume commercial program (100+ batches/year).
• Own PPQ studies for new scales, suites, and process improvements entering the network.
• Own CPV strategy, data trending, and dissolution-related process parameters.
• Lead investigations, deviations, CAPAs, and change controls; troubleshoot complex issues.
• Author regulatory submissions and support inspections and audits.

Skills

Process validation

CPV

PPQ

Coating science

Dissolution testing

Change controls

Technology transfer

Regulatory submissions

Leadership

Mentoring

Education

Bachelor's degree in Engineering/Pharma

MS/PhD/MBA preferred

Job description

**Job Description:**The Senior Manager, Manufacturing Sciences & Technology (MS&T) serves as the MS&T Product Lead for a commercial small molecule product, leading execution of the manufacturing science strategy across a high-volume, actively evolving commercial program. The product's complicated coating and challenging dissolution profile make process robustness, in-process control, and analytical alignment central to the role. The commercial network produces over 100 batches per year at a single U.S.-based CDMO partner, with several additional development activities, scale changes, and new manufacturing suites coming online in parallel.This Senior Manager position is responsible for leading execution of PPQ studies for new scales, suites, and process improvements entering the network, and is responsible for the execution and ongoing performance.The Senior Manager serves as the MS&T Subject Matter Expert (SME) for the product and owns manufacturing investigations, change controls, and continuous process verification (CPV) collection and evaluation across a high-throughput commercial program, with particular technical focus on coating uniformity, dissolution performance, and process capability at commercial scale. The role authors the technical content of regulatory submissions supporting global filings and launch expansion, including NDAs, CBE-30s, annual reports, and international market submissions, and supports production timing and capacity planning with Supply Chain and Commercial Operations to sustain an active, high-volume manufacturing calendar.The position is based in Cary, NC, with regular on-site presence expected at the Company's U.S.-based CDMO partner to support ongoing manufacturing and process and equipment upgrades.The base compensation range for this role is $160-175K. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions.# **Summary of Key Responsibilities**Product & Manufacturing Technical Leadership* Serve as the MS&T Product Lead for the commercial small molecule product throughout its lifecycle, including its expanding portfolio of scales, suites, and line extensions.* Serves as MTO lead for all inspection readiness and actual inspection activities for the Company.* Develop and execute manufacturing science strategies supporting a high-volume commercial program (100+ batches per year), supply continuity, regulatory compliance, and operational excellence.* Provide advanced technical leadership supporting commercial manufacturing campaigns, parallel scale changes, and new manufacturing suite start-ups at the CDMO.* Ensure manufacturing processes remain robust, compliant, validated, and inspection ready, with particular attention to coating uniformity and dissolution performance.* Drive continuous improvement initiatives focused on process capability, manufacturing reliability, product quality, and operational efficiency across a high-throughput program.Process Development, Validation & Lifecycle Management* Lead process development activities as needed for new scales, suites, or line extensions, including pre-PPQ technical ownership where a dedicated Process Development lead has not yet been assigned.* Lead execution of process validation and PPQ studies for new scales and suites, and own the process technically upon PPQ completion.* Own CPV strategy, execution, and data trending across the commercial program, with emphasis on coating, dissolution-related process parameters and inspection performance.* Lead manufacturing investigations, deviations, CAPAs, and change controls, and lead troubleshooting of complex technical issues related to coating, dissolution, and other critical quality attributes.* Lead implementation of process, scale, equipment, and site changes across parallel initiatives while maintaining validated process performance.Cross-Functional Technical Leadership* Partner closely with Process Development to ensure successful transfer of process knowledge and scientific understanding into manufacturing for new scales and suites. Responsible for ensuring all process history is property documented.* Collaborate with Quality Assurance to ensure manufacturing compliance, deviation management, investigations, CAPAs, and inspection readiness.* Work closely with Quality Control to ensure analytical and dissolution testing performance supports manufacturing and lifecycle management.* Partner with Supply Chain to support production timing, capacity planning, and supply continuity for a high-volume, multi-suite manufacturing calendar.* Build strong collaborative relationships across Manufacturing, Regulatory Affairs, Analytical Development, and Commercial Operations to support global launch expansion.External Manufacturing Leadership* Serve as a primary technical representative to the Company's U.S.-based CDMO partner, with regular on-site presence to support commercial production and parallel start-up activities.* Drive supplier technical performance through governance meetings, business reviews, performance metrics, and continuous improvement initiatives.* Support technical readiness for new manufacturing suites and scale changes coming on line at the CDMO.* Resolve complex manufacturing issues through collaboration with internal and CDMO technical teams.Regulatory & Quality Support* Author the technical content of regulatory submissions supporting global filings and launch expansion, including NDAs, regulatory updates, annual reports, and international market submissions.* Serve as technical representative during regulatory inspections and CDMO audits.* Ensure manufacturing processes remain compliant with global cGMP requirements across all commercial markets.* Support inspection readiness across internal functions and the CDMO partner.Technical Leadership & Organizational Development* Serve as the Manufacturing Sciences & Technology subject matter expert for the product, providing day-to-day technical guidance and sound scientific judgment on coating, dissolution, and process performance matters.* Coach and mentor Scientists, Engineers, and junior team members, building technical capability and an inclusive, learning-oriented culture.* Promote technical excellence through hands-on problem solving, knowledge sharing, and continuous learning.* Drive implementation of best practices and process improvements within MS&T.* Build alignment among internal stakeholders to ensure consistent execution of technical strategy across parallel initiatives.# **Required Qualifications and Skills**Education* Bachelor's degree in Engineering, Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biology, or related scientific discipline.* Advanced degree (MS, PhD, or MBA) strongly preferred.Experience* 10+ years of progressively responsible pharmaceutical or biotechnology manufacturing experience.* Demonstrated experience in technology transfer, process validation, CPV, lifecycle management, manufacturing investigations, and change controls.* Experience with film-coated, modified-release solid oral dosage forms and associated dissolution testing strongly preferred.* Experience supporting a high-volume commercial manufacturing program, including parallel scale-up or new suite qualification activities.* Experience supporting regulatory inspections and global regulatory submissions.* Demonstrated ability to mentor and develop junior technical staff within a global manufacturing organization and contract manufacturing network.Core Competencies* Strong technical understanding of pharmaceutical manufacturing processes.* Working knowledge of film coating and dissolution science for modified-release solid oral dosage forms.* Effective communication and coordination skills.* Strong coaching and mentoring skills with a focus on developing technical talent.* Ability to apply sound scientific and technical judgment to day-to-day execution decisions.* Ability to manage multiple parallel technical initiatives in a fast-paced commercial environment.* Fluent in English.Travel Requirements: 30-40%, domestic and international