Associate Director, Clinical Supply Chain (Biologics) at Abata Therapeutics

Waltham, Massachusetts, 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 or Master’s in a scientific discipline with 8+ years of relevant experience in clinical supply chain and logistics
Must have hands-on experience managing supply chain activities including but not limited to label

Responsibilities

Execute clinical supply chain activities including but not limited to labeling, packaging, distribution, inventory management, forecasting, IRT initiation, maintenance and expiry of clinical supplies
Author, review and/or approve clinical labels, packaging batch records, shipping documents, stability, clinical study, and pharmacy protocols
Serve as subject matter expert to generate label texts, distribution lanes, randomization codes, packaging specifications, and designs in compliance with regulations and GMPs
Support site initiation visits (SIV), trials and OLEs by providing timely delivery of supplies, CoAs, stability, expiration, handling and destruction information
Plan and adapt to changes against clinical demands, trial and protocol changes, expiration, and inventory management
Support clinical supply and logistics planning in support of global regulatory filings
Liaise with stakeholders to support timely approval and execution of SOPs, batch records, lot releases, change controls, deviations, and CAPAs
Support clinical distribution across US, Canada and EU through both IRT and manual driven site shipments and depot transfers
Verify with Quality the accuracy within blinded studies’ drug release, shipments & IRT setup
Identify and execute process improvements through report development and SOPs
Build strong relationships and partners with other leaders across CMC, quality, clinical operations, regulatory, and external CDMO/CPOs
Serve as person-in-plant (PIP) during label and packaging campaigns
20-25% travel in support of diligence and campaign execution at the CPOs

Skills

Clinical Supply Chain

Biologics

Labeling

Packaging

Distribution

Inventory Management

Forecasting

IRT

CMC

Clinical Trials

Regulatory

Quality

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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