Analytical Development Director - Job # 3009

Additional Information
  • Our Client offers an exceptional compensation package which will be commensurate on experience and great benefits.
  • For confidential consideration please submit a resume and salary history to claire@fullscalesolutions.com.
  • Please be sure to include the job number with your submission.
  • Full Scale Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
Client Synopsis:

Full Scale Solutions is currently recruiting for the following position located in Durham, NC.

Essential Duties and Responsibilities:

Our Client is a chemical contract manufacturer producing bulk API for leading biopharmaceutical companies.

The Analytical Development Director will lead and coordinate activities of the Analytical Development teams. He/she will manage general projects and assignments for teams. Will be responsible for ensuring that method development reports are produced in a timely fashion. Will work closely with customers to prepare documents for regulatory submission (e.g. IND filing / update, NDA filing etc.). This role will report to the Sr. VP of Operations and CEO.

Duties include, but are not limited to:

  • Manage method development activities and resources to meet project milestones and timeline.
  • Plan, design, implement and analyze laboratory experimentation to advance knowledge of drug substances.
  • Direct project team members in the initiation and execution of laboratory experimentation, considering safety, regulatory and economic factors.
  • Assist in preparation and review regulatory submissions for projects supported by the department’s development teams.
  • Develop chemical processes for manufacturing drug substances.
  • Lead projects related to delivery of Active Pharmaceutical Ingredient (API) or Drug Substance to support clinical studies and commercial needs.
  • Help advance the development of economical and state-of-the-art techniques to isolate, characterize, purify and mass-produce substances.
  • Use ingenuity and creativity when working on complex problems, where analysis of a situation or data requires evaluation of intangible variables.
  • Maintain in-depth knowledge of principles and theories and apply that knowledge to support company interests.
  • Demonstrate technical proficiency, employ scientific creativity, think independently and collaborate with others when suggesting experimental design and research strategies.
  • Work independently, creatively and think critically to determine appropriate resources for resolution of problems.
  • Continually motivate, assess, lead and develop the people in his/her organization and build them into a high-performing organization focused on results delivery, scientific and technical expertise and hands-on executive involvement.
  • Budget and manage cost, output and utilization to assure budget adherence.
  • Define, communicate and monitor key business indicators, identify variances and direct activities to achieve goals within budget.
  • Recruit and hire chemists under the Executive’s purview to drive the growth of the Company.
  • Establish and build strong organizational technical capabilities.
  • Play an ongoing and positive role in building and maintaining relationships with key customers.

Experience:

  • The successful candidate will likely have expertise and a strong leadership and technical background in API manufacturing.
  • 12+ years experience with PhD in a relevant scientific discipline, or experience with a MS/BS degree.
  • Must possess an in-depth technical knowledge of API process development and hands on demonstrated experience in the development of complex APIs
  • Present with a solid track record of building high-performing, multi-function pharmaceutical leadership teams. Must provide examples of improved performance by his/her teams across an array of metrics related to financial performance, quality, regulatory compliance and customer service.
  • The successful candidate will evidence good awareness and demonstrated experience of the fundamentals of the pharmaceutical supply chain, technical operations, quality, regulatory and product development functions and demonstrate strong strategic and tactical awareness.
  • The successful candidate must present with executive communication skills, both oral and written.
  • Must possess a proven track record in leading and developing organizations to consistently deliver results, both in terms of ongoing operations and with respect to quick resolutions of issues as they arise.
  • The successful candidate will demonstrate strong ethical principles and good business judgment; is skilled in making risk-based decisions from a regulatory, ethical and business perspective.
  • Must be able to travel to CA and other US states for extended periods.

The successful candidate will demonstrate the following competencies:

Results Oriented:
The Executive will demonstrate an excellent track record of consistently meeting objectives. Furthermore, the Executive will have a track record of utilizing innovation, continuous improvement, personal drive and strong relationship building skills to overcome the obstacles that inevitably arise during the course of business.

Collaboration and Influencing Skills:
The role requires a high degree of collaboration with peers and their organizations as well as the ability to influence internally and externally with partners at a senior level. The Executive must be able to listen, probe, push back and communicate in a compelling fashion. Finally, the Executive will have a strong executive presence, with demonstrable gravitas that enables influencing at the most senior levels of internal and external organizations.

Organizational Leadership:
The Executive will demonstrate the ability to recruit, deploy, motivate, coach and performance manage a multi-function organization.

Integrity and Confidence:
Though collaborative and open to varied perspectives, the Executive must be willing, when necessary, to stand alone on important issues of ethics or business judgment. The Executive will be able to effectively “speak truth to power” and will not shrink from advancing contrary points of view when he/she believes it important to do so.

Strategic Acumen:
The Executive will be a strong conceptual as well as analytical thinker, equally able to think insightfully at the enterprise level and to get “into the weeds” when necessary. He/She will have a strong understanding of the competitive and industry landscape in the generic drug industry, and will also demonstrate a detailed understanding of current and future value drivers in the sector. The Executive will have broad intellectual range and the ability to drive a strategic process to enable the functions in his/her organization to deliver results consistent with broader corporate objectives.

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