Executive Director Process Chemistry (Carlsbad)
Tyra Biosciences, Carlsbad, CA, United States
Tyra Biosciences, Inc. is seeking a highly qualified
Executive Director of Process Chemistry
to lead the development, optimization, and scale-up of small molecule drug substances from early development through commercialization. This role provides technical and operational leadership across process development, manufacturing, and regulatory activities while managing internal teams and external partners. Essential Functions and Responsibilities
Technical Leadership:
Lead process development, optimization, and scale-up
Oversee impurity control and ICH M7 strategies
Support process validation and control strategies
Author and review CMC sections for regulatory submissions
Manufacturing & CDMO Oversight:
Manage CDMO relationships and manufacturing campaigns
Support tech transfer and scale-up activities
Review deviations, investigations, and batch records
Regulatory & Quality:
Support IND, NDA, and MAA filings
Ensure compliance with ICH guidelines
Participate in inspections and audits
Leadership:
Lead and develop process chemistry teams
Manage project timelines and budgets
Collaborate cross-functionally across CMC disciplines
Education & Experience
PhD in Organic Chemistry or related field
15+ years of experience in process chemistry
Experience advancing at least one program to commercialization
Strong knowledge of GMP and regulatory requirements
Late-stage drug development experience on multiple trials (P3) required, through commercialization preferred.
Experience working in a fast-paced, agile working environment. Biotech experience preferred.
Strong communication skills, including formal presentations and informal scientific discussions, with internal and external stakeholders and experts.
Flexibility and adaptation to demanding timelines.
Team oriented person.
Fluent in spoken and written English.
Technical experience and familiarity with software programs and databases used by CROs and other organizations. Highly detailed with strong organization skills.
Up to 25% travel, including some international travel, may be required.
Pay Range and Benefits
Base Salary Range : $282,134 - $305,026 USD
Individual compensation will be determined based on factors such as work location, skills, education, training, and experience.
What we offer US-based Employees:
Competitive base, bonus, new hire and ongoing equity packages
The starting compensation range(s) for this role is for a full-time employee (FTE) basis
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment
Employer-paid Medical, dental, and vision insurance
Employer-paid life insurance, AD&D, short-term disability, long-term disability, and EAP coverage
401(k) Plan with a fully vested company match 1:1 up to 4% of contributions
Employee Stock Purchase Plan
14 -18 paid holidays, including office closure between December 25th and January 1st
Flexible vacation
Sick time
Fitness Program
Get Outdoors Program
Paid parental leave benefit
Tuition assistance
Job Type : Full-Time
Work authorization : United States (Required)
Work Location:
Remote
Equal Opportunity Employer : Tyra Biosciences, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.
Notice to Recruiters and Third-Party Agencies : The Talent Acquisition team manages the recruitment and employment process for Tyra. To protect the interests of all parties involved, Tyra will only accept resumes from a recruiter once a fully executed search agreement is in place. Agencies are hereby specifically directed not to contact Tyra employees directly in an attempt to present candidates. Tyra will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees.
Executive Director of Process Chemistry
to lead the development, optimization, and scale-up of small molecule drug substances from early development through commercialization. This role provides technical and operational leadership across process development, manufacturing, and regulatory activities while managing internal teams and external partners. Essential Functions and Responsibilities
Technical Leadership:
Lead process development, optimization, and scale-up
Oversee impurity control and ICH M7 strategies
Support process validation and control strategies
Author and review CMC sections for regulatory submissions
Manufacturing & CDMO Oversight:
Manage CDMO relationships and manufacturing campaigns
Support tech transfer and scale-up activities
Review deviations, investigations, and batch records
Regulatory & Quality:
Support IND, NDA, and MAA filings
Ensure compliance with ICH guidelines
Participate in inspections and audits
Leadership:
Lead and develop process chemistry teams
Manage project timelines and budgets
Collaborate cross-functionally across CMC disciplines
Education & Experience
PhD in Organic Chemistry or related field
15+ years of experience in process chemistry
Experience advancing at least one program to commercialization
Strong knowledge of GMP and regulatory requirements
Late-stage drug development experience on multiple trials (P3) required, through commercialization preferred.
Experience working in a fast-paced, agile working environment. Biotech experience preferred.
Strong communication skills, including formal presentations and informal scientific discussions, with internal and external stakeholders and experts.
Flexibility and adaptation to demanding timelines.
Team oriented person.
Fluent in spoken and written English.
Technical experience and familiarity with software programs and databases used by CROs and other organizations. Highly detailed with strong organization skills.
Up to 25% travel, including some international travel, may be required.
Pay Range and Benefits
Base Salary Range : $282,134 - $305,026 USD
Individual compensation will be determined based on factors such as work location, skills, education, training, and experience.
What we offer US-based Employees:
Competitive base, bonus, new hire and ongoing equity packages
The starting compensation range(s) for this role is for a full-time employee (FTE) basis
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment
Employer-paid Medical, dental, and vision insurance
Employer-paid life insurance, AD&D, short-term disability, long-term disability, and EAP coverage
401(k) Plan with a fully vested company match 1:1 up to 4% of contributions
Employee Stock Purchase Plan
14 -18 paid holidays, including office closure between December 25th and January 1st
Flexible vacation
Sick time
Fitness Program
Get Outdoors Program
Paid parental leave benefit
Tuition assistance
Job Type : Full-Time
Work authorization : United States (Required)
Work Location:
Remote
Equal Opportunity Employer : Tyra Biosciences, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.
Notice to Recruiters and Third-Party Agencies : The Talent Acquisition team manages the recruitment and employment process for Tyra. To protect the interests of all parties involved, Tyra will only accept resumes from a recruiter once a fully executed search agreement is in place. Agencies are hereby specifically directed not to contact Tyra employees directly in an attempt to present candidates. Tyra will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees.