[Remote] Director, Drug Substance and Early Development at Abata Therapeutics

Remote

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

PhD in Biochemical Engineering, Cell Biology, Biotechnology, or related field with 10+ years of relevant industry experience; or M.S. with 12+ years
Proven track record in upstream process development, cell line development, and bioreactor scale-up for biologics is highly preferred
Hands-on experience with monoclonal antibodies and/or Fc fusion proteins is required
Strong understanding of formulation development for early-phase biologics
Experience working with CDMOs and managing outsourced development/manufacturing activities
Familiarity with regulatory requirements for early- and late-stage biologics development
Excellent leadership, communication, and project management skills

Responsibilities

Lead MSAT activities for monoclonal antibodies and fusion proteins, from early development through clinical manufacturing
Oversee cell line development, clone selection, and characterization in collaboration with internal teams and external partners
Design and optimize bioreactor processes (shake flask to pilot scale) to ensure scalability, robustness, and regulatory compliance
Drive formulation development strategies for early-phase programs, ensuring compatibility with downstream processing and stability requirements
Collaborate cross-functionally with Analytical Development, Downstream Process Development, Quality, Regulatory, and Clinical Supply teams
Serve as a technical SME during tech transfer to CDMOs and during regulatory interactions
Author and review CMC sections of regulatory filings (IND/IMPD/BLA)
Evaluate and implement new technologies to enhance upstream development capabilities

Skills

Key technologies and capabilities for this role

Biologics developmentFormulationCell line developmentBioreactor scale-upTech transferProcess developmentMSATCross-functional execution

Questions & Answers

Common questions about this position

Is this role remote-friendly?

Yes, the role is open to remote work for US-based candidates.

What experience and education are required for this position?

A PhD in Biochemical Engineering, Cell Biology, Biotechnology, or related field with 10+ years of relevant industry experience is required, or an M.S. with 12+ years. Experience working with biologics and large molecules is also required.

What are the key responsibilities of the Director, Drug Substance and Early Development?

Key responsibilities include leading MSAT activities for monoclonal antibodies and fusion proteins, overseeing cell line development, designing bioreactor processes, driving formulation development, and collaborating cross-functionally.

What is the company culture like at Abata Therapeutics?

The company is building a culture centered on core principles to elevate patient care, in a high-impact, hands-on environment at a growing biotech that values building teams and driving cross-functional execution.

What makes a strong candidate for this role?

A strong candidate has a proven track record in upstream process development for biologics like monoclonal antibodies and fusion proteins, with experience in cell line development, bioreactor scale-up, formulation, and cross-functional collaboration including with CDMOs.

What is the salary or compensation for this position?

This information is not specified in the job description.

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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