Associate Director

5 days ago

Philadelphia, Pennsylvania, United States BioSpace, Inc. Full time
Job Title: Associate Director

At BioSpace, Inc., we are dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions.

Job Summary:

We are seeking an experienced Associate Director to lead our Contract Manufacturing team. The successful candidate will be responsible for managing projects at contract development and manufacturing organizations (CDMOs) for starting materials (i.e., radiopharmaceutical precursors) manufactured according to ICH Q7A, reference standards, and other key materials used in the manufacture or distribution of diagnostic imaging agent precursor, drug substance and drug product.

Key Responsibilities:
  • Lead the development activities of starting materials from early to late-stage projects in a phase-appropriate manner for assigned projects.
  • Lead projects including but not limited to optimization, technology transfer, scale-up, and process validation at contract development and manufacturing organizations (CDMOs) to ensure supply of phase-appropriate starting materials, reference standards, and other key materials as needed.
  • Oversee the manufacturing of the starting materials and reference standards at CDMOs.
  • Manage service agreement negotiations and change orders for contracts with CDMOs.
  • Author and review standard operating procedures, batch records, and specification documents relating to the manufacture and testing procedures of radiopharmaceutical precursors, reference standards, and other key materials.
  • Perform technical reviews to ensure compliance with manufacturing, testing procedures specifications.
  • Work cross functionally, coordinating the necessary internal resources to ensure timelines can be achieved and flag issues for resolution.
  • Resolve project issues from a technical and timing perspective and provide project management oversight (e.g., hold project review meetings as appropriate) to ensure timely deliverables to meet development program requirements.
  • Proactively solve potential supply chain issues for the radiopharmaceutical precursors and/or reference standards.
  • Identify, evaluate, and qualify as needed new CDMOs to ensure high quality and on-time execution of projects within the portfolio.
  • Contribute to resource planning, objective setting and any other business-related processes as appropriate.
  • Author and review CMC regulatory submissions, testing protocols, and technical reports relating to radiopharmaceutical precursor and reference standard development.
Requirements:
  • Ph.D. in chemistry, chemical engineering or other related field and 3+ years' experience in managing commercial pharmaceutical development and/or manufacturing, or Bachelors/Masters degree and 10+ years of experience.
  • Experience in managing CDMOs.
  • Highly adept in the phase appropriate compliance and regulatory aspects of GMP kilo lab scale manufacturing.
  • Thorough knowledge of cGMP drug substance manufacturing and quality control.
  • Experience in supply chain management of clinical trial material/commercial products highly desirable.
  • Ability to work independently in a highly focused manner.
  • Impeccable organizational skills.
  • Ability to manage multiple projects with competing priorities.
  • Superior written and verbal communication skills.
  • Excellent computer skills (e.g., Excel, Visio, and Project).
Additional Information:

Philadelphia, PA, or Remote. Must be willing and able to travel within the USA and worldwide 20% of time.

Lilly currently anticipates that the base salary for this position could range from between $112,500 to $165,000 and will depend, in part, on the successful candidate's qualifications for the role, including education and experience.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

Of course, the compensation described above is subject to change and could be higher or lower than the range described above.

Further, Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions.

If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance.

Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles

Our current groups include:

Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities.

Learn more about all of our groups.

#WeAreLilly

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