Drug Substance Manufacturing Lead

The Drug Substance Manufacturing Lead role will provide support for and overall management of the development/manufacture of Drug Substance (DS) at Puma’s established Contract Manufacturing Organizations (CMO’s) sites. This role is equivalent in scope and rewards package to Associate Director; however no direct reports. This role will be responsible for routine production support and batch record review, change controls, assisting with tech transfer activities, process development, technical process studies, deviations and troubleshooting, and process validation activities for the manufacture of Puma’s small molecule.  Ability to support writing and reviewing of key CMC sections of regulatory dossiers are also required for this position. DS manufacturing experience required.

Major Duties/Responsibilities

• Review and approve batch records, change controls, and deviations to ensure GMP compliance and operational success.
• Apply fundamental chemical engineering and industrial principles to help optimize the process based on previous experience.
• Lead, review, and contribute to technical assessments and reports for continuous process improvement.
• Assist in review of specifications for starting materials, process intermediates and active pharmaceutical ingredients
• In collaboration with colleagues in Quality and analytical groups manage and lead the CMO operations to achieve Puma’s goals for on-time manufacturing.
• Provide QC support of data for release and stability of DS and DP
• Assist in the preparation of various stability summaries and reports as well as authoring relevant stability sections of regulatory submissions

• The candidate will communicate across the organization to ensure key stakeholders are aware of project status, potential risks and their required action plans.
• Other duties as assigned

Skills & Abilities

• Excellent interpersonal and communication, presentation skills
• Excellent organizational and project management skills, work well under pressure.
• Ability to thrive in a small group setting with limited administrative support, developing and maintaining collaborative internal and external relationships.

Physical Demands

• Ability to remain seated for long periods of time while working on computer or referring to documents.
• Must have manual dexterity to operate computer keyboard and standard office equipment.
• Positions: Standing, walking, sitting, stooping
• Travel may be required (5-20%)

Education & Professional Experience

• < >Ph.D. or minimum of BS or MS degree in chemical engineering /chemistry, synthetic organic chemistry experience.
• < >Ph.D. degree with 10+ years or Master’s degree and 12-15 years of related experience – or- Bachelor’s degree with 15-18 years of direct experience
• High degree of technical understanding of chemistry and process technology.
• Proven track record of scaling-up and delivering kg quantities of drug substance in the appropriate physical form.
• Expert knowledge of NMR, HPLC, LCMS and other traditional organic chemistry laboratory techniques.

• Knowledge of small molecule analytical testing methods and impact on product quality specifications.
• Knowledge of Business process, project management and operational excellence experience.
• Experience in drafting, reviewing and submitting required documentation pertaining to the development and preparation of drug substance under cGMP environment.

• Special Training
• Think strategically to assess and improve processes to meet business needs globally.

• Ability to diagnose complex issues; develop and implement solutions by collaborating with other teams.
• Ability to lead teams and be able to influence internal and external stakeholders.

• Position Type/Expected Hours of Work
• This is a full-time position. Days and hours of work are Monday through Friday, 8:00 a.m. to 5 p.m. This position regularly requires long hours.

• Other Duties
• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that ae required of the employee for this job.Duties, responsibilities and activities may change at any time with or without notice.

• Equal Opportunity Employer
• Puma Biotechnology Inc is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, ethnicity, age, disability, veteran status, marital status, or any other characteristic protected by law.