June 9th, 2022 Pharmaceutical Development

Director Formulation Development

Remote

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Please be aware that Acadia has a mandatory COVID-19 vaccination policy for all employees.

Position Summary:

The Director in the Drug Product Development organization at Acadia is responsible for the formulation, primary packaging, and manufacturing process development for Acadia’s growing portfolio of drug candidates at all stages of development, and will provide technical oversight, expertise and guidance of externalized drug product development related activities. The scope includes the development of formulations, package, and process for all modes of administration including oral solid, liquid, and injectable dosage forms for candidates ranging from early stage development to validation and full cycle management. The person will lead activities relating to the above at the Contract Service Providers (CSPs) and will chip in both internally and externally in the resolution of complex technical issues and implementation of new manufacturing process technology for products intended for clinical and commercial distribution! The role will play a role in ensuring that we optimize development, reduce risk and accelerate the development of new assets for commercialization.

Primary Responsibilities:

  • Designs and develops formulations and manufacturing processes to support clinical trials, registration, and commercial product launch!
  • Evaluate and validate new drug product CSPs to support the development, scale-up, and commercialization of the new drug candidates in the Acadia pipeline.
  • Coordinate and facilitate everything leading up to the manufacturing of clinical formulations and finished dosage forms at CSPs and supervise technology transfers. Serves as a person-in-the plant at the CSP sites.
  • Ensures appropriate technical, scale-up, and production strategies and timelines are in place to meet clinical supply and registration needs and ensures technology transfer, validation, and regulatory outcomes are met.
  • Plans project-related scientific and technical activities, e.g. interpretation of results, evaluation of data, formulate relevant and scientifically based conclusions, writing and delivering technical reports.
  • Review clinical supply requirements with the clinical supply managers and plan the requisite manufacturing schedule with the CSPs to ensure an uninterrupted supply of clinical trial materials.
  • Perform risk assessments of the manufacturing process and product at key development achievements and address the findings with the relevant CSPs.
  • Prepares pharmaceutical development reports and other technical documentation required for regulatory submissions, including authoring, review, and approval of requisite sections of the IND, CTA, IMPD, NDA, MAA or other filings.
  • Authors and reviews technical reports and documents such as drafting SOPs, reviews MBRs, BPRs, development reports, and relevant documents prepared by CSPs.
  • Adheres to cGMP work practices and works closely with the Quality Assurance to ensure strict compliance with applicable GXP procedures and compliance requirements. Assist the CSPs in preparation for health authority inspections and for pre-approval inspections.
  • Develop an expansive work environment, crafting staff development opportunities, encouraging innovation, advocating a quality culture, maintaining safety, and achieving dedication.

Education/Experience/Skills:

  • Master’s degree in Pharmaceutical Sciences or a related field. Ph.D. degree is highly preferred. An equivalent combination of relevant education and applicable job experience may be considered.
  • A desired 15 years’ experience with dynamically growing responsibility in pharmaceutical development with a focus on oral solid and liquid dosage forms and some experience developing injectable and other dosage forms.
  • 5 years in a leadership role is required and experience leading cross-functional teams and skilled at handling CROs and CMOs.
  • Shown ability to write technical and or scientific documents and success in the field of formulations and oral dosage form development, with some exposure to combination products, modified release and injectable dosage forms.
  • Comprehensive understanding of the dosage form manufacturing PD, scale-up, optimization, validation processes, and formulation development process for new chemical entities.
  • Extensive knowledge of cGMPs and past experience supporting NDAs or other marketing authorization applications.
  • Proficient at crafting and driving a clear vision among team members efficiently aligning resources and activities to achieve functional area and division goals.
  • Ability to encourage and energize others through expert technical knowledge, personal leadership, influence, and thorough planning and work towards timely and appropriate results.
  • Flexibility to travel domestically and internationally.

Physical Requirements:

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently of remote locations. The employee must occasionally lift and/or move up to 20 pounds. The ability to travel to domestic and international locations is required.

#LI-REMOTE #LI-MH1

 

What we offer you:

  • Competitive base, bonus, new hire and ongoing equity packages
  • Medical, dental, and vision insurance
  • 401(k) Plan with a fully vested company match 1:1 up to 5%
  • Employee Stock Purchase Plan with a 2-year purchase price lock-in
  • 15+ vacation days
  • 14 paid holidays plus one floating holiday of your choice, including office closure between December 24th and January 1st
  • 10 days of paid sick time
  • Paid parental leave
  • Tuition assistance

EEO Statement:

Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every single one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We would strongly encourage you to apply – especially if the reason you are the best candidate isn’t exactly as we describe it here.

It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.

As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia’s career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete our Reasonable Accommodation Request Form or contact us at [email protected] or 858-261-2923.

Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodation given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.