Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Director, Pharmaceutical Development - Sterile Drug Product
Location: Bedford, NH
Position Overview:
We are looking for an experienced leader to drive Sterile Pharmaceutical development of Biologics and small molecules, with specific focus on Biologics e.g. ADCs, Proteins, Peptides, Oligos, mAbs etc. The individual can serve as a subject matter expert in Sterile formulation, process and analytical development.The individual will be expected to build a motivated team of formulation and analytical scientists. Prior experience with building a high-performing team would be beneficial. Prior experience in CDMO environment, working with customers and managing expectations and driving projects would be ideal. Prior experience with Potent drug products and setting up a new development facility would be beneficial.Reporting Structure:
This position will have matrix reporting, with primary reporting to V.P., Pharmaceutical Sciences, and dotted line reporting to the site GM.Formulation, analytical and process development teams based on the site will report to the position.Essential Duties and Responsibilities:
Responsible for the leadership and strategy of the Pharmaceutical Development groups within PCI Pharma Services, Bedford.Responsible for provision of technical excellence for development projects (Biologics, small molecules) in line with industry expectations.To efficiently deliver the client project portfolio of the Pharmaceutical Development Department to agreed project milestones.Member of the Site Leadership Team and business partner to Engineering, Quality, EHS, HR, Finance leaders.Responsible for delivering Pharmaceutical Development revenue and to manage department budget.To partner with Business Development to provide technical support and act as site technical SME to attract new clients and projects.Oversee in partnership with department SMEs technical scopes for new projects and proposals.Partner with Marketing for generating thought leadership articles, white papers, presenting webinars etc.To act as a source of Technical Expertise within the company, keeping abreast of developments within the field by attendance of technical seminars/conferences, LinkedIn learning and scientific papers.To work with the GM and the Continuous Improvement Manager to achieve continuous improvements site targets, and continuous improvement mindset within development groups.To evaluate new complimentary technologies for the site and the business.To ensure all staff achieve the agreed quality compliance targets for the site, supporting client and regulatory audits as required.To be responsible for the selection, training and development, quarterly reviews, and performance of development staff.Ensure that all staff within the area of responsibility comply with PCI Pharma services Environmental Health and Safety Policies and Procedures.Authority for expenditure as defined in the purchasing authority levels document.Qualifications:
Education:
Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering or a related field with at least 12+ years of experience in an industrial setting.M.S. in Pharmaceutical Sciences, Chemistry, Chemical Engineering in a relevant field with at least 17+ years of laboratory experience in an industrial setting.Experience:
Extensive knowledge and experience in pharmaceutical development - formulation, process, and analytical of Sterile small molecules, Biologics e.g. ADCs, Proteins, Peptides, Oligos mAbs etc.Prior experience in CDMO industry would be greatly beneficial. Prior experience in setting up and operating development laboratories. Experience in recruiting, developing leaders and managing technical teams.Deep understanding of the design, development, optimization, and tech transfer of Biologics.Solid understanding of phase appropriate development of sterile drug products.Understanding of drug product manufacturing of potent compoundsProficient in analyzing and interpreting complex datasets from multiple methodologies.Demonstrated experience in cross-functional and functional leadership roles with strong collaboration and stakeholder relationship management skills.Self-motivated leader with exceptional communication skills.Comprehensive knowledge of ICH and FDA regulations and guidance for biologics e.g. ADCs, Proteins, Peptides, Oligos, mAbs etc.Personal Qualities and Behaviors:
Highly driven and PassionateGrowth Mind-setSelf ConfidenceResilience and Customer focused#LI-MS1
Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Diversity, Equity, and Inclusion (DEI) are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.