Senior Director, Pharmaceutical Development

Your New Company!
At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future at Altasciences.

We are better together and together We Are Altasciences.

About The Role

The Senior Director of Pharmaceutical Development leads the pharmaceutical development function at Altasciences CDMO Philadelphia LLC.

What You'll Do Here

• Lead, plan and manage phase appropriate drug product pharmaceutical development activities intended for pre-clinical and clinical manufacturing,
• Leading, planning and managing technical and business-related activities associated with phase appropriate drug formulation and process development intended for preclinical through GMP phase 1 manufacturing,
• Participating in Business Development meetings with new clients to support scientific and project strategy,
• Lead drug development formulation design of experiments, characterization and process development,
• Participate in business development meetings with new clients to support scientific and project strategy,
• Provide scientific expertise and oversight of drug formulation and process development,
• Work closely with internal functions to ensure fast turnaround and the progression of clients' development projects,
• Working closely with client project teams throughout the development cycle of the project,
• Work closely with business development and operations teams on project proposals and costing models.
• Work closely with client project teams throughout the development cycle of their project.
• Engage in scientific meetings, facilitate scientific and data exchange for both internal and external forums,
• Engage in scientific meetings, facilitate scientific and data exchange for both internal and external forums,
• Perform literature searches and evaluation of client projects to provide solutions to challenging technical issues for various types of innovative drug product delivery systems for new therapies,
• Report and manage the performance metrics for the pharmaceutical development function.
• Accountable for the department resources and budgets.
• Maintain a positive culture of technical excellence, collaboration, transparency and communication,
• Lead and author high quality scientific publications to promote CDMO services according to marketing plans.
• Provide guidance, coaching, and leadership to staff which are aligned with Altasciences' values,
• Provide guidance, coaching, and leadership aligned with Altasciences' values and culture to a team of scientists and engineers in support of drug product development, optimization, and manufacturing scale up,
• Ensure staff receives appropriate knowledge, skill development and career growth opportunities,
• Retain and recruit key talent within the pharmaceutical development function,
• Work closely in collaborative manner with clients' project teams,
• Serve as a Subject Matter Expert for oral solid dosage form development and manufacturing,
• Serve as a Subject Matter Expert for pharmaceutical development and manufacturing activities,
• Design and select preclinical and clinical formulation technology platforms,
• Design and select preclinical and clinical formulation development technology platforms,
• Oversee the strategy and execution of development and characterization studies to evaluate formulations, primary container closure systems, and drug product manufacturing,
• Develop strategies and execute plans for drug product development from first-in- human formulations through development in accordance with project timelines and deliverables,
• Develop strategies and execute plans for drug product pharmaceutical development accordance with project timelines and deliverables,
• Identify the appropriate platform technology to support drug product development and manufacturing for preclinical and clinical supplies,
• Lead formulation and process development, technology transfer, scale-up, and manufacturing activities,
• Work closely with Analytical Services to ensure development and validation of phase-appropriate methods and review related stability studies,
• Review and approve project related documents, protocols, and final reports,
• Work closely with the Quality department to establish and improve standard operating procedures as they relate to the drug development cycle and related risk-assessment and control strategy,
• Support due diligence of business development opportunities,
• Actively engages in creating a positive and transparent culture with key internal and external stakeholders,
• Maintain a positive culture of technical excellence, collaboration, transparency and communication, talent development, and goal achievement,
• Develop leaders by providing an environment that encourages ongoing personal and professional development,
• Accountable for developing and managing the pharmaceutical development function resources and budgets,
• Review technical reports and author CMC ICH CTD Module 3 sections of regulatory submissions related to drug product from early to late stage of development, as applicable.

What You'll Need to Succeed

M.Sc./ B.Sc. in Pharmaceutical Science, Chemical Engineering, Chemistry, Biology or related scientific fields

• 10+ years' experience in pre-formulation and formulation development for small molecules, preferably solid and liquid dosage forms, injectables
• Experience in formulation and process development from early to late-stage phase appropriate development and IND/NDA filing,
• Working knowledge of phase appropriate GMP requirements for drug product development cycle,
• Working knowledge of ICH, FDA and EMA regulations and guidelines for pharmaceutical development and manufacturing,
• Experience in building and leading formulation development function in pre-formulation, formulation development, process selection and scale up, and oversight of drug product development manufacturing,
• Proficient in Microsoft Office,
• Excel in team settings with ability to be agile, think critically, and work.

• Yes, strong people management leadership skills

• Continuous Education Certificates
• Business Management Certificate is a plus

• Strong expertise in pharmaceutical development technology for oral solid and liquid dosage forms
• Technical knowledge of Good Documentation Practices is required

• English; Excellent written and verbal communication skills

• Demonstrated interpersonal and facilitation skills
• Ability to work in a collaborative team-based environment
• Adherence to Altasciences core values

What We Offer:

Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.

Altasciences' Benefits Package Includes:

• Health/Dental/Vision Insurance Plans
• 401(k)/RRSP with Employer Match
• Paid Vacation and Holidays
• Paid Sick and Bereavement Leave
• Employee Assistance & Telehealth Programs

Altasciences' Incentive Programs Include:

• Training & Development Programs
• Employee Referral Bonus Program
• Annual Performance Review

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MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH

Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Join us at Altasciences!