Biotechnology, Pharmaceuticals

Senior Manager, Manufacturing

Redwood City, CAOnsiteFull TimeSenior$173,430–$204,030 /yrPosted 2 months agoVisa sponsorship available

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Required skills

Drug Substance Manufacturing
Small Molecule API
GMP API manufacturing
CMOs
Process Validation
Regulatory Submission
CMC development
Quality
Regulatory
Supply Chain

Nice to have

NDA
MAA
Commercial Launch Readiness
Post-Approval Changes
Process Validation Lifecycle
Continued Process Verification

Role summary

Seeking a Senior Manager, Drug Substance Manufacturing to oversee late-stage development and commercial readiness for small molecule APIs. Responsibilities include managing external CMOs for GMP API and non-GMP starting material manufacturing, supporting process validation, regulatory submissions, and ensuring robust GMP execution. The role requires technical and operational leadership in drug substance manufacturing, process transfer, deviation investigation, and change control. Collaboration with Quality, Regulatory, Supply Chain, Process Chemistry, Analytical Development, and external partners is essential. A Master's or Ph.D. with 8+ or 5+ years of relevant experience is preferred.

For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases.

Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today.

Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com.

We are seeking an experienced Senior Manager, Drug Substance Manufacturing to support late-stage development and commercial readiness activities for small molecule active pharmaceutical ingredients (APIs) , including oversight of GMP API manufacturing and non-GMP starting material manufacturing activities. This role will be responsible for managing external manufacturing activities at contract manufacturing organizations (CMOs), supporting process validation and regulatory submission readiness, and ensuring robust execution of GMP manufacturing campaigns for late phase and commercial API programs as well as reliable supply of starting materials manufactured under non-GMP conditions.

The successful candidate will provide technical and operational leadership for drug substance manufacturing, process transfer, process validation, deviation investigation, change control, and continuous improvement activities. This position requires strong experience in small molecule API manufacturing, late-stage CMC development, GMP operations, and cross-functional collaboration with Quality, Regulatory, Supply Chain, Process Chemistry, Analytical Development, and external partners.

Responsibilities:

Lead and manage external GMP drug substance manufacturing activities for late phase small molecule API programs

Oversee manufacture and supply of regulatory starting materials and key intermediates under non-GMP conditions, as applicable, to support late-phase API manufacturing programs

Manage external partners involved in non-GMP starting material manufacture, including review of manufacturing plans, process descriptions, batch documentation, quality expectations, timelines, and supply readiness

Partner with Process Chemistry, Quality, Regulatory, and Supply Chain teams to ensure appropriate control, documentation, qualification, and change management for starting materials used in GMP API manufacture

Assess risks associated with starting material sourcing and manufacture, including supplier reliability, process consistency, impurity profile, traceability, and potential impact on downstream GMP API manufacturing

Support supplier qualification, technical assessments, and lifecycle management activities for starting materials and key raw materials manufactured under non-GMP conditions

Oversee technology transfer, scale-up, process optimization, engineering batches, PPQ readiness, and commercial launch preparation

Serve as the primary technical and operational interface with CMOs for API manufacturing campaigns

Review and approve batch records, campaign protocols, manufacturing instructions, process validation protocols, and manufacturing reports

Support process validation strategy, including PPQ planning, continued process verification, and process performance monitoring

Lead or support deviation investigations, OOS/OOT assessments, root cause analysis, CAPA development, and manufacturing risk assessments

Ensure manufacturing activities are executed in compliance with cGMP, ICH Q7, ICH Q11, regulatory commitments, and internal quality requirements

Partner with Process Chemistry and Analytical teams to ensure robust process understanding, impurity control strategy, and process control strategy

Support preparation and review of CMC regulatory sections for IND, NDA, MAA, Type II variations, supplements, and health authority responses

Review and assess proposed changes related to raw materials, starting materials, suppliers, process parameters, equipment, manufacturing sites, and analytical methods

Manage CMO performance, manufacturing timelines, issue escalation, and cross-functional alignment on project deliverables

Support supplier qualification, raw material strategy, manufacturing readiness, and lifecycle management activities

Contribute to continuous improvement initiatives to enhance process robustness, manufacturing efficiency, and supply reliability

Preferred Skills, Qualifications and Technical Proficiencies:

Direct experience supporting NDA, MAA, or commercial launch readiness for small molecule APIs

Experience with post-approval changes, process validation lifecycle, continued process verification, and regulatory inspection support

Familiarity with quality risk management principles and impurity control strategies, including genotoxic impurities and nitrosamine risk assessments

Experience supporting supplier qualification, raw material change assessments, and CMO audits

Prior experience in outsourced development/manufacturing models

Strong technical judgment and problem-solving skills

Ability to lead through influence in a cross-functional matrix environment

High attention to detail and commitment to GMP compliance

Effective communication with internal stakeholders and external manufacturing partners

Strong ownership, accountability, and ability to drive deliverables to completion

Preferred Education and Experience:

Master’s or Ph.D. degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related scientific discipline. Relevant experience of 8+ years with a Master’s degree, or 5+ years with a Ph.D required

Strong experience in small molecule API manufacturing, preferably supporting late phase clinical, validation, or commercial programs

Demonstrated experience working with CMOs and managing external manufacturing campaigns

Experience managing non-GMP manufacture of regulatory starting materials, advanced intermediates, or key raw materials used in small molecule API manufacturing

Familiarity with expectations for starting material justification, supplier qualification, impurity control, traceability, and change control in late-phase or commercial API programs

Solid understanding of cGMP requirements, ICH Q7, ICH Q11, process validation, and regulatory expectations for API manufacturing

Experience with process transfer, scale-up, PPQ preparation, deviation investigations, CAPAs, and change controls

Strong technical understanding of synthetic organic chemistry, impurity control, process parameters, in-process controls, and manufacturing documentation

Experience contributing to CMC regulatory submissions and health authority responses is preferred

Excellent project management, communication, technical writing, and cross-functional collaboration skills

The pay range that the Company reasonably expects to pay for this headquarters-based position is $173,430 – $204,030; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

Applicants must be currently authorized to work in the United States on a full-time basis.

For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link.

Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.

Please visit our website at: https://www.corcept.com/

Corcept is an Equal Opportunity Employer

Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.

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Senior Manager, Manufacturing

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