MSAT (Associate) Director at Orca Bio

Menlo Park, California, United States

Orca Bio Logo
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
BiotechnologyIndustries

Requirements

Candidates must hold a Bachelor's degree in Engineering, Chemistry, Pharmacy, or a related scientific discipline, with a PhD in Chemical Engineering, Biochemistry, or Analytical Chemistry being preferred. They should possess a minimum of 8 years of relevant experience, and demonstrate strong leadership skills within a manufacturing environment.

Responsibilities

The MSAT (Associate) Director will lead a team of scientists and engineers to support the launch, scale-up, and maintenance of late-stage and commercial manufacturing processes, establishing and maintaining performance metrics, developing strategies for process improvement, implementing process improvements based on data analysis, driving the execution of studies and qualifications, coordinating process transfers, troubleshooting technical issues, leading data preparation for regulatory submissions, mentoring the MSAT team, and ensuring team capabilities meet future needs.

Skills

GMP
Process Transfer
Scale-up
Data Analysis
DOE
CAPA
Change Management
CPV
Process Qualification
Deviation Management
Tech Transfer
Process Optimization
Regulatory Compliance
CMC

Orca Bio

Develops and commercializes cell therapies

About Orca Bio

Orca Bio operates in the biotechnology sector, specifically focusing on cell therapies that utilize the body's own cells to treat diseases. The company works to enhance these therapies, aiming to make them safer and more effective for patients. Orca Bio's products are primarily used by healthcare providers who administer these therapies to patients as part of their treatment plans. Unlike many competitors, Orca Bio emphasizes a strong team culture and values communication with stakeholders, keeping them informed about the company's progress and developments. The goal of Orca Bio is to improve patient outcomes through advanced cell therapies, addressing conditions that currently have limited treatment options.

Menlo Park, CaliforniaHeadquarters
2016Year Founded
$186.8MTotal Funding
SERIES_DCompany Stage
Biotechnology, HealthcareIndustries
51-200Employees

Benefits

Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Unlimited Paid Time Off
401(k) Retirement Plan
Parental Leave

Risks

Emerging competition from BlueRock Therapeutics in stem cell therapies.
Aspen Neuroscience's advancements in personalized stem cell therapies pose a threat.
Competitors' focus on iPSC-derived therapies may overshadow Orca Bio's offerings.

Differentiation

Orca Bio focuses on high-precision cell therapies for cancer and autoimmune diseases.
Their lead product, Orca-T, shows promising relapse-free survival rates in clinical trials.
Orca Bio's therapies aim to replace diseased blood and immune systems with healthy ones.

Upsides

Orca-T demonstrated 87% relapse-free survival in a Phase 1b/2 trial.
FDA's expedited approval pathways could accelerate Orca Bio's market entry.
Advancements in gene editing enhance the efficacy of Orca Bio's cell therapies.

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