Director CMC Formulation Development and Manufacturing
Director CMC Formulation Development and Manufacturing
Posted on :
11-04-2025
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1 Vacancy
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Monthly Salary
$ 194284 - 236848
Vacancy
1 Vacancy
Posted on :
11-04-2025
Job Description
IDEAYA Biosciences (NASDAQ: IDYA) is a public clinicalstage precision medicine oncology company committed to the discovery development and commercialization of targeted therapeutics for patient populations with high unmet clinical needs. Our approach integrates extensive capabilities in identifying and validating translational biomarkers with small molecule drug discovery to select patient populations most likely to benefit from the therapies we are developing. We have developed an industry leading platform and pipeline in precision medicine by applying these capabilities across multiple approaches such as direct targeting of oncogenic pathways and synthetic lethality which represents an emerging class of precision medicine targets. We believe this diversified approach will enable us to deliver the right medicine to the right patient to drive a more robust clinical response. IDEAYA has established strategic collaborations with GSK Merck Pfizer and Gilead but whollyowns or controls its four mostadvanced clinical programs and we are committed to building a bestinindustry organization to deliver our precision medicines to the people who need them.
When youre at IDEAYA you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine which means we all have a high internal drive that is at the very core of every person at IDEAYA. We are inquisitive ask deep questions and are datadriven innovators who like to collaborate and use teamwork to move science forward. For more information please see www.ideayabio.
Notice to Agencies and Recruiters: All open positions and candidate activity are strictly managed through Human Resources. Please note that our policy is that recruiters do not contact employees/hiring managers directly to solicit business and/or present candidates. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Please note that failure to comply with this request will be a factor in developing a professional relationship with IDEAYA Bio. Inquiries regarding developing a recruiting relationship with us may be directed to
Position Summary:
We are seeking an experienced and highly motivated Director CMC Formulation Development and Manufacturing to join our multidisciplinary team based in South San Francisco. This role requires the candidate to work collaboratively with the related crossfunctional teams to support our drug discovery pipeline. The successful candidate will be responsible for but not limited to those listed below.
This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.
What youll do:
- Lead the formulation efforts in facilitating drug development by managing multiple CDMOs across all stages of drug development (preclinical Phase I III and commercial)
- Author and review technical development reports batch records campaign reports change controls corrective and preventative actions deviations and investigation.
- Author and review necessary technical sections in IND/IMPD/NDA supporting global CMC regulatory submission and remain current on Health Authority guidance and expectations.
- Develop DP strategies to meet program and project development targets ensure timely and efficient delivery of highquality products and facilitate regulatory approvals.
- Represent DP/CMC and participate in cross functional project teams and manage multiple priorities in a fastpaced dynamic environment and enact quick problem solving to ensure ontime supply of drug to support PK/PD efficacy DRF and pilot toxicology studies INDenabling activities and clinical trials across a portfolio of programs.
- Collaborate closely in crossfunctional teams including but not limited to Medicinal Chemistry DMPK Analytical Chemistry Process Chemistry Toxicology Quality Project Management CMC Regulatory Development Sciences and Clinical Pharmacology to achieve project goals.
- Proactively communicate with and work closely with other functions to align DP and CMC strategies to achieve and maintain aggressive timelines to ensure goals are met
- Lead dosage form selection formulation development process optimization and scaleup activities ensure robust costeffective and scalable manufacturing processes.
- Lead the evaluation selection and management of CDMOs to perform formulation and process development and GMP manufacture.
- Oversee technology transfer activities at CDMOs to ensure successful manufacturing and provide technical expertise in troubleshooting and resolving issues as necessary.
Requirements:
- Ph.D. in Pharmaceutics Chemistry Chemical Engineering or related discipline with a minimum of 12 years or M.S with a minimum of 15 years of development experience and demonstrated ability in leading crossfunctional groups. Late phase and commercial experience are a plus.
- Demonstrated track record of success in delivering timely of DP and CMC activities ranging from preclinical INDenabling and NDA material supplies through GMP clinical trial supplies and commercialization.
- Demonstrated expertise in small molecule formulation development (traditional oral solid dosage and enabling formulations such as ASD and HME is a plus) scaleup and manufacturing and phase appropriate control strategy and specification development.
- Experience with analytical techniques for small molecules and oral solid dose products with proficiency in UPLC/HPLC dissolution and solidstate characterization techniques such as DSC/TGA PLM XRPD and laser diffraction PSD method. Track records to interpretate the analytical data and application to support formulation development.
- Good understanding of physicochemical properties of API PK/PD correlation and develop the phase appropriate formulations
- Strong understanding of Quality systems including SOPs manufacturing record review batch release and disposition Good Documentation Practices cGMP data traceability Deviations and Change Management.
- Demonstrated knowledge and application of current industry and compendial standards and regulatory authority guidance and expectations including ICH FDA MHRA and EMA guidelines and USPNF Ph. Eur BP and JP compendia
- Experience in managing global CDMOs and reviewing documentation and ensuring proper guidelines are followed.
- Exceptional problemsolving skills and ability to quickly adapt and shift focus as needed
- Excellent interpersonal and communication skills for internal and external collaborations
- Ability to multitask in a fastpaced dynamic environment while demonstrating a calm and positive attitude and a superior work ethic
- Excellent interpersonal communication and decisionmaking skills
- Able to travel domestic and internationally to oversee DP development and manufacturing at CDMOs
$194284 $236848 a year
At IDEAYA Biosciences we care about our employees and strive to provide a marketcompetitive total rewards package including base pay an annual performance bonus company equity and generous health and wellbeing benefits. The expected salary range for this role that is based in our South San Francisco California office is $194284 $236848.
The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the office location where this open position is located the final candidates experience within their profession experience in the disease areas we are striving to make an impact in as a company length of time within the industry educational background and performance during the interview process.
The Company complies with all laws respecting equal employment opportunities and does not discriminate against applicants with regard to any protected characteristic as defined by federal state and local law. This position requires you to work onsite at the Companys facilities with partial workfromhome flexibility and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore this position requires you to be fully vaccinated from COVID19 subject to reasonable accommodations for medical or religious reasons and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a twodose COVID19 vaccine series or a singledose COVID19 vaccine. The vaccine must have been FDA approved have emergency use authorization from the FDA or for persons fully vaccinated outside of the U.S. be listed for emergency use by the World Health Organization.
Total Rewards:
Along with our inspiring mission and highly collaborative and inclusive environment IDEAYA offers a competitive total rewards package that reflects our payforperformance philosophy where employees are eligible to be considered for meritbased salary increases company discretionary shortterm incentive plan participation and company discretionary stock option awards (based on board approval). Our comprehensive benefits package includes but is not limited to medical/dental/vision coverage 100 company paid for employees and 90 company paid for dependents) 401k ESPP and wellness programs.
IDEAYA is an equal opportunity employer. In accordance with applicable law IDEAYA does not discriminate in hiring or otherwise in employment based on race color religion sex national origin age marital or veteran status disability sexual orientation or any other legally protected status. EOE/AA/Vets.
Required Experience:
Director
Employment Type
Full-Time
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