Senior Manager, Clinical Supply Chain at Abata Therapeutics

San Diego, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Bachelor’s degree in a scientific or pharmaceutical discipline
6+ years of biotechnology/pharmaceutical industry experience with direct experience in clinical supply chain management
Inventory management and vendor oversight experience in all phases of drug development for biologics with global clinical supply distribution
Strong knowledge of cGMP, GCP regulations, and Annex 13 and VI
Solid understanding of clinical research protocol requirements and experience developing IRT specifications
Familiarity with biologics manufacturing processes (highly desirable)
Experience with logistic systems and shipping
Effective communication and direction skills
Ability to identify project risks and rapidly develop and implement risk mitigation strategies in a fast-paced environment with changing priorities
United States work authorization

Responsibilities

Prepare, maintain, and periodically re-evaluate demand forecasts and supply strategies to ensure uninterrupted IMP supply to clinical sites while minimizing product waste throughout the clinical trial
Contribute to and review Interactive Response Technologies (IRT) specifications; manage IRT systems in alignment with the overall supply strategy
Collaborate with cross-functional teams to create and approve labeling designs in compliance with regulatory requirements
Manage packaging activities at the Clinical Packaging Organization (CPO) and coordinate with QA for release
Contribute to the preparation and review of clinical trial pharmacy manuals and packaging batch records
Oversee distribution and inventory of clinical trial material across depots and sites
Manage drug return, destruction process, and accountability at the depots
Coordinate material shipments from CDMO to storage facilities and CPOs
Review and approve third-party vendor invoices, ensuring accuracy and compliance with contractual terms
Partner with QA on quality events, investigations, deviations/CAPA, batch record review and drug disposition
Manage expiry date extensions, documentation, and related distribution activities
Participate in forecast meetings with Clinical Operations; prepare presentation materials and communicate inventory updates and operational strategies
Identify and lead process improvement initiatives to enhance efficiency and compliance
Perform other responsibilities as assigned

Skills

Supply Chain Management

Demand Forecasting

Interactive Response Technology (IRT)

Labeling Compliance

Packaging

Inventory Management

Distribution

Quality Assurance (QA)

CMC

Clinical Operations

Regulatory Compliance

CAPA

Batch Record Review

Vendor Management

Process Improvement

Abata Therapeutics

Develops therapies for autoimmune diseases

About Abata Therapeutics

Abata Therapeutics develops therapies for autoimmune diseases, focusing on type 1 diabetes. Their main product, ABA 201, is a Treg cell therapy aimed at patients with some remaining beta cell function. This therapy works by utilizing regulatory T cells to improve patient outcomes. Unlike many competitors, Abata targets a specific niche within the autoimmune disease market and collaborates with partners like ElevateBio for process development and manufacturing. The company's goal is to transform treatment options for autoimmune diseases through advanced research and development.

Cambridge, MassachusettsHeadquarters

2021Year Founded

$184.8MTotal Funding

EARLY_VCCompany Stage

BiotechnologyIndustries

11-50Employees

Risks

Intensifying competition from companies like Sangamo Therapeutics may impact Abata's market share.

Stringent FDA scrutiny on manufacturing could delay Abata's clinical trials.

Rising clinical trial costs pose financial risks to Abata's pipeline progression.

Differentiation

Abata focuses on Treg cell therapies for autoimmune diseases like MS and diabetes.

Their lead product, ABA 201, targets type 1 diabetes with remaining beta cell function.

Abata's strategic partnership with ElevateBio enhances their manufacturing capabilities.

Upsides

Recent investment from Bristol Myers Squibb boosts Abata's Treg therapy pipeline development.

FDA's accelerated approval pathways may expedite Abata's clinical trials.

Growing autoimmune disease prevalence increases demand for Abata's innovative treatments.

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