Senior Director, Formulation and Drug Product Development

Remote

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, BiologicsIndustries

Requirements

Candidates should possess a Ph.D. in Pharmaceutical Sciences, Chemistry, Biology, or a related scientific field, with at least 10 years of experience in protein drug product development, including formulation development, process development, aseptic manufacturing, and support of clinical studies. Strong knowledge of regulatory requirements and quality systems, particularly as they relate to biologics, is essential, along with experience in collaborating with cross-functional teams and external partners.

Responsibilities

The Senior Director, Formulation and Drug Product Development will develop drug product and formulation development strategies to advance clinical assets, develop clinical and commercial formulations for protein therapeutics, define and develop robust biologics drug product manufacturing processes, support clinical studies through dose preparation development and clinical stability studies, and collaborate with cross-functional teams to prepare clinical documentation. They will also oversee tech transfer to and manufacturing at CDMOs, and deliver robust drug product supply for clinical trials and launch/commercialization.

Skills

Formulation Development

Drug Product Development

Protein Drug Product

Process Development

Aseptic Manufacturing

Tech Transfer

CDMO Management

Clinical Trial Supply

Commercialization

Quality Compliance

Regulatory Compliance

Biotechnology

Antibody Engineering

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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