Associate Director, Upstream, Manufacturing Sciences & Technology (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

PhD or Master’s in an Engineering discipline or Biological Sciences field with at least 8 years of experience in upstream manufacturing from relevant work in a manufacturing sciences and technology (MS&T) environment
Strong expertise in CHO cell culture, scale up, media formulations and bioreactor operations. Experience developing cell culture processes for monoclonal antibodies is a plus
Solid understanding of process parameters, product quality, and troubleshooting strategies enabling successful execution of phase appropriate manufacturing campaigns
Track record of successful tech transfers to CDMOs with direct experience in late stage clinical and commercial manufacturing
Experience in late stage manufacturing, including process characterization, FMEA, and PPQ campaigns
Direct experience in robust data analysis via industry standards

Responsibilities

Serve as a subject matter expert for upstream cell culture development and manufacturing at CDMOs
Lead tech transfer and scale-up activities, ensuring robust, consistent, and cost-effective upstream processes
Support batch record review, in-process sampling plans, release protocols, review SOPs, change controls, deviations, OOS/OOT investigations, and CAPAs
Serve as person-in-plant (PIP) during drug substance manufacturing campaigns
Conduct risk assessments and gap analysis to support late-stage development and commercial readiness
Manage drug substance manufacturing campaigns and timelines ensuring seamless execution, timely completion and handoff to downstream teams
Apply QbD principles to define process parameters and product quality attributes that support late-stage process optimization and control strategy
Analyze and incorporate data from process and manufacturing runs in relevant regulatory filings
Coordinate, review and draft relevant sections of the regulatory filings (IND, IMPD) ensuring timely completion of relevant CMC sections
Travel up to 20-25% to support CDMO activities

Skills

Key technologies and capabilities for this role

Upstream ManufacturingBiologicsTech TransferScale-upProcess ValidationCDMOCMCRegulatory SubmissionsGap Assessments

Questions & Answers

Common questions about this position

What is the work location and arrangement for this role?

The position is hybrid and requires being in-office 3 days per week in Waltham, MA.

What salary or compensation is offered for this position?

This information is not specified in the job description.

What key skills and experience are required for this role?

The role requires expertise in upstream cell culture development and manufacturing at CDMOs, experience leading tech transfer and scale-up activities, and knowledge of QbD principles, risk assessments, gap analysis, and regulatory filings.

What is the company culture like at Oruka Therapeutics?

The company is building a core team and seeks passionate individuals eager to contribute to an engaged, inclusive, and positive company culture while being part of something bigger.

What makes a strong candidate for this Associate Director role?

Ideal candidates are experienced in leading late-stage upstream manufacturing, collaborate cross-functionally in a fast-paced environment, and have a passion for developing best-in-class biotherapeutics as part of a growing team.

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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