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Manager, Process Improvement
Walmart
BENTONVILLE, AR
- $80,000 to $155,000 USD / year
The team leads the development of essential reporting and metrics to support the Licensing Department’s growth. Responsibilities include creating databases and SharePoint sites, automating…
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Senior Manager, Electrical Engineering
Walmart
BENTONVILLE, AR
- $90,000 to $180,000 USD / year
The Senior Manager, Electrical Engineering is responsible for leading enterprise electrical safety and reliability programs across Walmart, Sam’s Club, and Supply Chain facilities. This…
Added 4 mins ago
BN
Manager, Inventory Control & Process Improvement
Blue Nile
NY · New York, NY
- $85,000 to $120,000 USD / year
The Manager, Inventory Control & Process Improvement is a newly created, highly visible role responsible for the accuracy, control, and health of Blue Nile's inventory. The role owns…
Added 4 mins ago
Assistant Brand Manager, Marketing
Blue Nile
Remote, United States
The Assistant Brand Manager, Marketing – Blue Nile will support the execution of brand marketing initiatives that enhance awareness, engagement, and customer loyalty. This role is ideal for…
Added 4 mins ago
BN
Manager, Visual Merchandising
Blue Nile
Remote, United States
- $100,000 to $130,000 USD / year
Blue Nile is seeking a Manager of Visual Merchandising to define and execute the in-store visual expression of the Blue Nile brand. This role will be responsible for how product is…
Added 7 mins ago
Technology Consulting Senior Principal
Accenture
Clayton, MO
As a Senior Manager, you demonstrate leadership, strategic thinking, and a collaborative approach to delivering client value. You are motivated to build trusted client relationships,…
Added 8 mins ago
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Assistant Project Manager - Construction
GPAC
Kalamazoo, MI
- $70,000 to $90,000 USD / year
Ready to take the next step in your construction career? We're looking for an organized, motivated Assistant Project Manager to join a growing construction team in Grand Rapids, MI!
Added 20 mins ago
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Civil Engineer - Land Development Background
GPAC
Fort Collins, CO
- $85,000 to $115,000 USD / year
Execute complex assignments utilizing judgment in the evaluation, selection, and modification of standard engineering techniques and procedures under the guidance of the Project Manager
Added 20 mins ago
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Civil Engineer - Land Development Background
GPAC
Fort Worth, TX
- $85,000 to $115,000 USD / year
Execute complex assignments utilizing judgment in the evaluation, selection, and modification of standard engineering techniques and procedures under the guidance of the Project Manager
Added 24 mins ago
Major Projects - Project Manager
Vistra Nuclear Operations Company
Glen Rose, TX
The Senior Project Manager will be responsible for managing small to large scale O&M and Capital projects associated with and including budget maintenance, and adherence to projects…
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Design Engineer
GPAC
Irvine, CA
- $80,000 to $120,000 USD / year
Must be able to work on a team of other designers and under a Project Manager
Added 30 mins ago
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Land Development PE
GPAC
Los Angeles, CA
- $80,000 to $140,000 USD / year
We are seeking a Professional Engineer (PE) to join our Land Development team in a Project Manager role. This is a great opportunity for someone looking to lead projects, manage client…
Added 32 mins ago
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Senior Electrical Engineer
GPAC
Atlanta, GA
- $110,000 to $140,000 USD / year
This position offers the opportunity to serve as a Project Manager or Lead Electrical Engineer on complex building projects while partnering with multidisciplinary teams to deliver…
Added 32 mins ago
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Civil Project Manager
GPAC
Atlanta, GA
- $110,000 to $145,000 USD / year
We're partnering with a respected engineering consulting firm seeking a Civil Project Manager (PE) to lead a diverse portfolio of land development and public infrastructure projects. This…
Added 33 mins ago
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Senior Electrical Engineer
GPAC
Austin, TX
- $110,000 to $140,000 USD / year
This position offers the opportunity to serve as a Project Manager or Lead Electrical Engineer on complex building projects while partnering with multidisciplinary teams to deliver…
Added 33 mins ago
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Senior Electrical Engineer
GPAC
Philadelphia, PA
- $110,000 to $140,000 USD / year
This position offers the opportunity to serve as a Project Manager or Lead Electrical Engineer on complex building projects while partnering with multidisciplinary teams to deliver…
Added 33 mins ago
G
Civil Project Manager
GPAC
Philadelphia, PA
- $110,000 to $145,000 USD / year
We're partnering with a respected engineering consulting firm seeking a Civil Project Manager (PE) to lead a diverse portfolio of land development and public infrastructure projects. This…
Added 34 mins ago
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Senior Electrical Engineer
GPAC
Des Moines, IA
- $110,000 to $140,000 USD / year
This position offers the opportunity to serve as a Project Manager or Lead Electrical Engineer on complex building projects while partnering with multidisciplinary teams to deliver…
Added 34 mins ago
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Civil Project Manager
GPAC
Baltimore, MD
- $110,000 to $145,000 USD / year
We're partnering with a respected engineering consulting firm seeking a Civil Project Manager (PE) to lead a diverse portfolio of land development and public infrastructure projects. This…
Added 34 mins ago
G
Senior Electrical Engineer
GPAC
Baltimore, MD
- $110,000 to $140,000 USD / year
This position offers the opportunity to serve as a Project Manager or Lead Electrical Engineer on complex building projects while partnering with multidisciplinary teams to deliver…
Added 35 mins ago
G
Land Development PE
GPAC
Los Angeles, CA
- $80,000 to $140,000 USD / year
We are seeking a Professional Engineer (PE) to join our Land Development team in a Project Manager role. This is a great opportunity for someone looking to lead projects, manage client…
Added 36 mins ago
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Senior Electrical Engineer
GPAC
Las Vegas, NV
- $110,000 to $140,000 USD / year
This position offers the opportunity to serve as a Project Manager or Lead Electrical Engineer on complex building projects while partnering with multidisciplinary teams to deliver…
Added 36 mins ago
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Senior Electrical Engineer
GPAC
Denver, CO
- $110,000 to $140,000 USD / year
This position offers the opportunity to serve as a Project Manager or Lead Electrical Engineer on complex building projects while partnering with multidisciplinary teams to deliver…
Added 36 mins ago
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Senior Electrical Engineer
GPAC
Dallas, TX
- $110,000 to $140,000 USD / year
This position offers the opportunity to serve as a Project Manager or Lead Electrical Engineer on complex building projects while partnering with multidisciplinary teams to deliver…
Added 38 mins ago
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Civil/Site Land Development PE - Olathe, KS
GPAC
Olathe, KS
- $110,000 to $140,000 USD / year
Civil/Site Land Development Engineer (PE/Project Manager)

Uniquity Bio Inc.

Associate Director, Analytical Development & Quality Control

Malvern, PA, United States

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Job details

Posting language: English
Posted: Nov 6, 2026

Original job description

Uniquity Bio is a clinical-stage biotechnology company committed to putting science and patients first. We exist to develop transformative new medicines for immune-mediated diseases, and we’re looking for bright-minded professionals driven by a desire to advance science and make a difference for people in need. Our lead asset, solrikitug, is a highly-potent TSLP inhibitor now in Phase 2 clinical trials for asthma, chronic obstructive pulmonary disease (COPD), and eosinophilic esophagitis (EoE) indications.

Join us in building an organization where people and science thrive together. You’ll have the opportunity to make a meaningful impact while working alongside a talented, agile team in an environment where ideas move quickly, colleagues are trusted, and quality remains a cornerstone.

Position Overview Reporting to the Sr. Director, Analytical Development and Quality Control (AD & QC), the Associate Director AD & QC will lead analytical development and quality control activities to support the development, characterization, manufacturing, and regulatory approval of biopharmaceutical products. This individual will be responsible for establishing and maintaining robust analytical methods, overseeing method qualification, transfer, validation, and lifecycle management, and ensuring the successful execution of drug substance and drug product release and stability testing.

The role will provide scientific and technical leadership across analytical development, QC, product characterization, comparability, and control strategy development, with a focus on advancing programs through late-stage development, process performance qualification (PPQ), and Biologics License Application (BLA) submission.

The successful candidate will ensure analytical activities comply with applicable GMP requirements and global regulatory expectations while fostering strong collaboration across internal functions and external partners, including contract manufacturing organizations and contract laboratories. This individual will also contribute to CMC regulatory submissions, proactively identify and resolve technical and quality challenges, and help drive analytical readiness to support product commercialization.

The role requires a strong scientific foundation in protein chemistry, analytical methods, and bioassays, along with demonstrated leadership, sound judgment, and the ability to influence cross-functional teams in a dynamic, fast-paced environment.

Key Responsibilities

Responsibilities include, but are not limited to:

Develop and implement robust, reliable analytical methods to support the product development lifecycle.
Lead analytical method qualification, validation, and transfer for drug substance (DS) and drug product (DP) release and stability testing.
Oversee GMP and non-GMP stability studies, ensuring scientifically sound study design, execution, and compliance with applicable quality standards and regulatory requirements.
Manage the reference standard lifecycle, including the establishment and maintenance of a two-tier reference standard system to support product registration and ongoing quality control.
Review and approve QC raw data and analytical documentation packages for release and stability testing, ensuring data integrity, accuracy, and compliance with GMP requirements.
Lead late-stage product characterization studies to support critical quality attribute (CQA) identification and the development of the product control strategy.
Oversee DS and DP comparability assessments to support process changes, continuous improvement, and product lifecycle management.
Collaborate closely with internal cross-functional teams and external partners, including contract manufacturing organizations (CMOs) and contract laboratories, to ensure timely and high-quality execution of analytical activities.
Maintain current knowledge of applicable GMP requirements, regulatory guidance, and industry best practices.
Author and review technical reports, analytical documentation, and Chemistry, Manufacturing, and Controls (CMC) sections of global regulatory submissions.

Qualifications

Bachelor's degree or higher (advanced degree preferred) in analytical chemistry, biochemistry, or a related scientific discipline, with at least 10 years of experience in the biopharmaceutical industry.
Strong scientific foundation in protein chemistry, analytical methods, and biological assays.
Significant experience in analytical development and/or quality control within the biopharmaceutical industry.
Demonstrated expertise in biologics analytical method development, qualification, transfer, validation, and lifecycle management, including an understanding of pharmaceutical and biopharmaceutical manufacturing processes.
Experience in late-stage monoclonal antibody (mAb) drug product development preferred.
Experience preparing and supporting analytical deliverables for process performance qualification (PPQ) and Biologics License Application (BLA) submissions preferred.
Experience with drug-device combination products preferred.
Experience managing analytical activities and deliverables with external partners, including CMOs and contract laboratories, preferred.
Ability and willingness to travel domestically and internationally to support external site oversight and management activities.
Demonstrated ability to influence stakeholders, build effective working relationships, and drive alignment across internal teams and external partners.
Excellent written and verbal communication skills, with the ability to clearly convey technical concepts, project objectives, and results.
Strong problem-solving, critical-thinking, and negotiation skills, with the ability to proactively identify risks, develop practical solutions, and achieve business objectives in a dynamic, cross-functional environment.

Work Environment

At Uniquity Bio, we believe every team member has an impact on the patients we aim to serve. We are a nimble team with a rigorous approach to drug development that requires collaboration and transparency to maximize value, reduce risk, and deliver meaningful, best-in-class products. We are looking for self-starters who enjoy working in a complex, collaborative environment and are motivated to bring critical new medicines to people around the world. We are a small, fast-paced organization with a talented team of in-house employees and external consultants. Candidates must be self-motivated and able to work both independently and collaboratively to achieve success and impact in our dynamic work environment.

This is a U.S.-based position. Team members who live within commuting distance of our Malvern, PA or San Diego, CA office locations are expected to spend time in the office, and remote employees are expected to travel to an office on a regular basis. Specific details for both local and remote staff will be discussed and agreed upon on a case-by-case basis with the employee’s manager. Business travel may be required depending upon the specific needs of the position.

The above job description is not intended to be all-inclusive. Requirements of the position may change from time to time based on business needs.

Uniquity Bio is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.

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More about this job

Skills

Quality control
Clinical trials
Leadership
Good manufacturing practices
Collaboration
Regulatory compliance
Documentation
Process improvement
Analytical chemistry
Manufacturing processes
Communication skills
Problem solving
Critical thinking
Negotiation

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