Principal/Senior Scientist, Process Development

Martinez, CA
Full Time
Experienced

The Role

We are seeking a highly motivated and experienced Scientist to join our team. The Principal Scientist will play a key role in the design, optimization, and scale-up of chemical processes for the manufacturing of our innovative blood filtration devices

A Few Key Responsibilities

  • Provide strategic leadership and direction to the Manufacturing team focused on CMC activities, including process development, manufacturing, and regulatory compliance for Class Ill Medical Device/Biotech.
  • Lead and mentor a team of scientists and engineers to drive innovative approaches for the synthesis, scale-up, and manufacturing of ExThera products.
  • Collaborate with cross-functional teams including analytical /organic chemistry, formulation,
  • to ensure seamless integration of CMC activities into product development programs.
  • Oversee the design and execution of methods and process validations to optimize process efficiency and ensure product quality and consistency.
  • Manage technology transfer activities between R&D and manufacturing sites, ensuring successful implementation of processes at commercial scale.
  • Develop and maintain strong relationships with external partners including contract manufacturing organizations (CMOs}
  • Stay current with industry trends, regulatory requirements, and guidelines related to CMC for biotech/pharmaceutical/medical device products and implement best practices to ensure compliance.
  • Drive continuous improvement initiatives within the Manufacturing organization to enhance efficiency, productivity, and quality of CMC processes.
  • Provide technical leadership and support for troubleshooting manufacturing issues and implementing corrective actions as needed.
  • Generate and maintain comprehensive documentation including batch records, technical reports, and regulatory submissions.
What You Bring
  • PhD in Organic Chemistry or related field with a minimum of 8 years of industry experience in pharmaceutical/biotech/class Ill medical device environment with a focus on CMC. Required.
  • Demonstrated expertise in organic chemistry, process development, and manufacturing scale-up is a must.
  • Strong knowledge of regulatory requirements and guidelines (e.g., FDA, ICH} related to CMC for pharmaceutical/biotech/class Ill medical device products.
  • Excellent communication, presentation, and interpersonal skills with the ability to effectively collaborate with internal and external stakeholders.
  • Strategic mindset with the ability to develop and execute innovative solutions to complex technical challenges.
  • Detail-oriented with a commitment to maintaining high-quality documentation and regulatory compliance.
Relocation benefits are not offered for this role. The expected salary range for this position based on the primary location of Martinez, Ca is $140,295 and $189,856.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. 
Share

Apply for this position

Required*
We've received your resume. Click here to update it.
Attach resume or Paste resume
Attach resume as .pdf, .doc, .docx, .odt, .txt, or .rtf (limit 5MB) or Paste resume

Paste your resume here or Attach resume file

To comply with government Equal Employment Opportunity and/or Affirmative Action reporting regulations, we are requesting (but NOT requiring) that you enter this personal data. This information will not be used in connection with any employment decisions, and will be used solely as permitted by state and federal law. Your voluntary cooperation would be appreciated. Learn more.
Invitation for Job Applicants to Self-Identify as a U.S. Veteran
  • A “disabled veteran” is one of the following:
    • a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or
    • a person who was discharged or released from active duty because of a service-connected disability.
  • A “recently separated veteran” means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.
  • An “active duty wartime or campaign badge veteran” means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.
  • An “Armed forces service medal veteran” means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.
Veteran status


Voluntary Self-Identification of Disability
Voluntary Self-Identification of Disability Form CC-305
OMB Control Number 1250-0005
Expires 04/30/2026
Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Please check one of the boxes below:

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

You must enter your name and date
Human Check*