Drug Substance Director

Primary Function of Position:

This position will lead the drug substance function of the CMC department. This individual will manage all small molecule drug substance development activities for both of Intuitives late stage development programs to ensure timely regulatory filings.  This individual will be responsible for chemical route scouting process optimization technology transfer and drug substance manufacturing activities at external CMOs to support the nonclinical and clinical portions of each program. This individual will ensure that 1 appropriate scientific and technical standards are established; 2 robust data are available to support regulatory filings; and 3 in partnership with quality assurance that appropriate quality controls are implemented and executed. 

Roles & Responsibilities:

• Develop and execute strategy that is phaseappropriate and well positioned for accelerated development of small molecule programs.
• Lead and manage internal personnel contractors and consultants ensuring effective onboarding training and task . Foster a collaborative work environment allocate resources efficiently and maintain clear communication channels to achieve project milestones and highquality outcomes.
• Provide direction and technical expertise to Contract Manufacturing Organizations (CMO) partners guiding CMC work to ensure development programs are on track aligned with project objectives and meet regulatory requirements. 
• Develop a comprehensive control strategy for starting materials intermediates and drug substance and convert this understanding into specific unit operation requirements to achieve a robust manufacturing process.
• Guide CMO to execute process development studies according to the principal of Quality by Design specification justification studies to establish limits process characterization studies to identify proven acceptable ranges (PARs) of critical process parameters (CPPs) including identification of edge of failure characterization of drug substances to identify critical quality attributes (CQAs).
• Provide direction to the CMO in terms of drug substance development strategies and technical expertise.
• Drive continuous improvements in the drug substance development process through technological innovations risk management and problem solving whilst balancing against fastest path to approval.
• Collaborate with crossfunctional teams including Quality Assurance Regulatory Affairs and other CMC functional groups to drive the successful development of drug substances.
• Actively contribute to writing key pharmaceutical development sections of regulatory documents IND/IMPD/NDA.

Qualifications :

Skills Experience Education & Training:

• Minimum Ph.D. in Organic Chemistry Chemical Engineering or a related field with a minimum of 10 years of small molecule biopharmaceutical industry experience.
• Management experience with direct reports including hiring training and team development.
• Wellversed and demonstrated success in the application of QbD principles.
• Proven track record of successfully leading small molecule programs from preclinical clinical and validation stages through regulatory approval.
• Strong knowledge of regulatory requirements and guidelines (e.g. FDA EMA NMPA ICH) pertaining to drug substance development and commercialization.
• Understanding of product lifecycle management is beneficial
• Experience managing contract manufacturing organizations (CMOs) and external partners/vendors.
• Proven negotiation skills in contract management as well as influencing key stake holders in QA and regulatory with robust risk management assessments.
• Excellent leadership and project management skills with the ability to effectively prioritize and manage multiple projects simultaneously.
• Indepth understanding of cGMP principles documentation requirements and experience working in a regulated manufacturing environment.
• Proactive mindset with a focus on anticipation of potetntial development hurdles problemsolving and planning to meet project timeline goals.
• Strong analytical and critical thinking abilities with a keen attention to detail.
• Ability to travel up to 30.

Additional Information :

Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID19.  Details can vary by role.

Intuitive is an Equal Employment Opportunity / Affirmative Action Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.

EEO and AA Policy

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.

We provide marketcompetitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target salary ranges are listed.

Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID19.  Details can vary by role.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.

Mandatory Notices

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.

We provide marketcompetitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target salary ranges are listed.

Remote Work :

No

Employment Type :

Fulltime