Associate Director, GMP Quality Control - Lincoln, United States - Sumitomo Pharma

Description

Associate Director, GMP Quality Control

Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need spanning psychiatry & neurology, oncology, urology, women's health, rare disease, and cell & gene therapies.

The company's diverse portfolio includes several marketed products and a robust pipeline of early- to late-stage assets.

Building on Sumitomo Pharma's 125-year legacy of innovation, SMPA leverages proprietary in-house technology platforms and advanced analytics capabilities to accelerate discovery, development, and help bring novel therapies to patients sooner.

SMPA is a Sumitomo Pharma company. For more information, visit Sumitomo- \_cromwell\_myovant\_com/Documents/Documents/072023%20Transition%20documents/JDs/Sumitomo-) .

Job Overview

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Associate Director of GMP Quality Control, who oversees GMP compliance of manufacturing, testing and release activities for SMPA, its partners, contract testing laboratories, and suppliers of drug substances and drug products used for investigational clinical trials and/or commercial phases.

The Associate Director ensures compliance with GMPs, SMPA procedures and applicable global Regulatory guidelines by providing oversight and management of the global contract testing laboratories in partnership with the Company's CMC Team.

The Associate Director also participates in drafting and reviewing CMC sections of the IND, IMPD and BLA/NDA submissions.

This role works with internal stakeholders and external partners to ensure released drug supply within expiry date is available to support commercial product and clinical program needs.

Job Duties and Responsibilities

• Represent QC on cross-functional project teams.
• Provide quality management oversight of analytical activities with domestic and international contract manufacturing organizations and testing laboratories, and with internal and external partners.
• Review and approve test results conducted at contract manufacturing and testing sites for SMPA products.
• Review and approve stability program protocols, test results, trend analyses, reports, and recommend product expiry extensions/reductions, as applicable. Lead and/or present at the Stability and Specification Review Committees for GMP Drug Substance and Drug Product programs.
• Review and approve Quality Events, Investigations, CAPA, Change Controls, and Complaints in eQMS.
• Lead OOS, OOT, and analytical quality events in eQMS. Provides guidance to internal and external partners on Phase 1b investigations to ensure investigations are conducted according to SMPA requirements, Quality Agreements, and regulatory expectations. Review and approve test plans and ensure timely investigation and closure of OOS/OOT.
• For CMOs with aseptic processing, review media fills, and environmental monitoring data as it relates to lot release, change control and facility re-starts.
• Partners with CMC to conduct method transfers and validation of new or existing analytical methods for release and stability testing of drug substance, drug product and other materials, to domestic and international contract manufacturing organizations and testing laboratories.
• Contribute to product development by making recommendations for manufacturing controls, sampling and testing to ensure product quality and compliance with GMPs from development through commercialization.
• Support partner relationships where the same drug product testing and stability may be shared across global programs and the company's external partners, to sustain global uniformity of analytical methods across labs.
• Coordinate the extension of expiry dates and communicate changes to contract manufacturing organizations, testing laboratories, clinical sites and regulatory affairs as needed.
• Responsible for compliance with regulatory filings and therefore must have experience in a Quality Assurance and/or Quality Control function for marketed pharmaceutical products or clinical trial materials. Review regulatory IND, IMPD, CTD and BLA/NDA CMC sections. Perform QC check for regulatory submissions to ensure accuracy and data integrity.
• Enhance quality control practices and optimize internal processes by contributing to the preparation, review and approval of standard procedures and electronic systems.
• Participate, as needed, in audits of contract laboratory sites and support annual Risk Assessments as part of the Supplier Quality program.
• Create, edit, and manage Quality Agreements for contract laboratories.
• Experience in conducting product release activities for clinical and commercial drug substances and drug products; including review and approval of Master Batch Records, Executed Batch Records, batch release, and stability testing documentation, and batch disposition desired.
• Other duties as needed.

Key Core Competencies

• Quality leader and quality culture promoter within the global organization.
• Ability to establish and maintain a positive working relationship within Sumitomo Pharma America (SMPA) and with their external business partners as it relates to area of responsibility.
• Excellent verbal and written communication skills, including ability to interact effectively with senior management and partners.
• Self-motivated, flexible, and able to prioritize work and handle multiple assignments in a fast-paced environment, while maintaining a high level of quality and compliance.
• Strategic and tactical in the planning and execution of quality initiatives and activities.
• Leader who values and demonstrates collaboration and teamwork.
• Advanced knowledge and use of software applications, including LC chromatographic analyses, statistical applications, and quality management systems (e.g. Veeva).

Education and Experience

• 8 years of experience required, with relevant experience in biotech or pharmaceutical industry with most experience in a Quality role.
• Minimum of Bachelor's degree in a scientific discipline (e.g., biology, chemistry, engineering, pharmacy) or relevant field of study. Master's degree preferred.
• Experience working in more than one product area (e.g. solid oral dose, injectables, combination products), and therapeutic area (e.g. oncology, urology, regenerative medicine) within Quality Control a plus.
• Advanced knowledge of GMP manufacturing and/or market release of pharmaceutical dosage forms and/or combination products desired.
• Must have in-depth knowledge of global regulations including FDA, EMA, MHRA and PMDA guidelines and have a proven track record in implementing these guidelines in fast growing environments.
• Experience in evolving GMP related quality systems, policies, and procedures to ensure compliance with evolving standards as well as improving the efficiency of related workflows.
• Well versed in analytical and characterization procedures for biopharmaceuticals and small molecules including HPLC, GC, MS, electrophoresis, immunoassays, bioburden, endotoxin, moisture, assay, and dissolution testing.
• Expertise in design of method validation, transfer, and stability studies consistent with regulatory, quality, and pharmaceutical best practices (e.g., USP, ICH).
• Experience with managing external CMO and contract laboratory environments.
• Experience desired with drug delivery devices, diagnostics, biomarker, and genetic testing.
• Strong ability to analyze complex issues to develop relevant and realistic plans, programs, and recommendations.

Disclaimer:

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification.

They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
The base salary range for this role is $129,100 to $161,400.

Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state.

Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter.

Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.

Confidential Data :
All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.

Compliance :

Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.

Mental/Physical Requirements :
Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

Sumitomo Pharma America (SMPA)
is an Equal Employment Opportunity (EEO) and Affirmative Action employer
Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce.

All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

For more information about EEO and the Law, please visit the following pages:
Equal Employment Opportunity is THE LAW )
EEO is the Law Poster Supplement
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Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need spanning psychiatry & neurology, oncology, urology, women's health, rare disease, and cell & gene therapies.

The company's diverse portfolio includes several marketed products and a robust pipeline of early- to late-stage assets.

Building on Sumitomo Pharma's 125-year legacy of innovation, SMPA leverages proprietary in-house technology platforms and advanced analytics capabilities to accelerate discovery, development, and help bring novel therapies to patients sooner.

SMPA is a Sumitomo Pharma company. [For more information, visit Sumitomo- (s.sumitomo-) ]

At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.

Our
Mission
_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_

Our
Vision
_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_