Director, Pharmaceutical Development-Oral Solids

Avanir Pharmaceuticals

Avanir Pharmaceuticals

North America
Posted on Wednesday, August 2, 2023
Director, Pharmaceutical Development is an experienced leader in the development of pharmaceutical products in a virtual environment with extensive technical, strategic and leadership expertise in guiding teams and driving results. Leveraging their deep technical proficiency and proven cross-functional collaboration, they will empower decision making while serving as a product development expert to all relevant internal and external functional representatives (CMOs, Manufacturing, Supply Chain, Quality Assurance, Regulatory, etc.) to deliver products that are commercially viable and that meet the highest standards of quality and safety for patients. In addition, the role requires a successful track record of carrying out development, manufacturing, and commercialization activities including a demonstrated ability to work effectively with CDMOs. The position reports to Executive Director, CMC & Product Development.

Job Description

  • Represent Drug Product team in CM&C teams and support the formulation and process development of small molecules and other novel synthetic modalities in clinical development
  • The candidate will engage and work with external partners (CDMOs) to ensure all the drug product formulation & processes are robust, scalable, and well characterized before validation and commercial manufacturing activities.
  • Lead manufacturing process validation activities and transfers with external CDMOs ensuring design of validation strategy is in alignment with business needs, regional & global regulatory compliance and support continued process verification post validation.
  • Process owner in leading CDMOs on establishing continuous process verifications, driving process improvements, and providing technical leadership during quality investigations of complex deviations/non-conformances.
  • Develop and implement a plan to identify key external business partners who can aid in the development of complex drug product formulations to drive Otsuka’s life cycle management plans.
  • The individual will lead in the design and execution of validation strategies, qualifying manufacturing unit operations and sites to ensure supply plan meets the regional demand forecast.
  • Develop and maintain a collaborative working relationship with OPCJ and Alliance Partners where applicable to insure effective project implementation.
  • The individual is expected to work closely with regulatory in preparation/coauthoring global regulatory filings and addressing CMC related queries.
  • Partner with manufacturing, quality and regulatory. lead quality investigations and data analysis as SME to address deviations, non-conformances and implement change controls to ensure timely release of batches and ensure CAPAs are in place.
  • In conjunction with Commercial colleagues, identify critical CDMOs and other external partners for life cycle management programs that will meet or exceed the preferred target product profile
  • Establish strategic relationships with academia and start-ups to accelerate growth and innovation. Drive a strong innovation agenda for the team leading to publications, patents, and industry wide influence.
  • Manage budgets, schedules, and performance requirements to meet project goals.
  • Review and approve technical documentation including protocols, master batch records, and reports.
  • Travel: Up to 25% of the time – occasional international travel to partner and/or contractor facilities related to engineering, GMP and PPQ runs.

Qualifications/ Required

Knowledge/ Experience and Skills:

  • Advanced degree in pharmaceutical or engineering sciences or pharmacy with a minimum 15 years of experience in the pharmaceutical industry with 10+ years managing technical resources
  • The ideal candidate must be an outstanding leader with a proven track record of strategic planning and development of advanced synthetic molecules from clinical manufacturing, regulatory approval to commercial launch.
  • The candidate must have exceptional organizational and communication skills, be capable of communicating strategic plans to upper management, summarize data, and effectively manage interactions with stakeholders across functions
  • Experience in managing US/international CDMOs for the manufacture of non GMP and cGMP DS, DP, and device
  • Working knowledge of ICH and FDA guidelines and global regulations
  • Experience with regulatory, QA, and cGMP requirements for biologics. Assist in OOS investigations, determination of root cause, and implementation of appropriate CAPA.
  • Experience with IND and NDA filings; knowledge of relevant FDA regulations and guidelines is required
  • Track record of successfully driving and managing programs, overcoming challenges, and managing risks
  • Manage budgets, schedules, and performance requirements to meet project goals
  • Excellent communication and interpersonal skills in working across the organization

Disclaimer

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Equal Opportunity Employer

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

Annual Salary :

Minimum $174,491.00 - Maximum $260,935.00, plus annual incentive: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.

Company benefits: comprehensive medical, dental, vision and prescription drug coverage, company provided Basic Life, AD&D, Short-term and Long-term Disability insurance, tuition reimbursement, a 401(k) match, PTO allotment each calendar year, paid holidays, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

Disclaimer:

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

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