Reporting to the Director, Drug Development, the newly created appointment, Senior Manager, Drug Development will lead CMC activities - formulation development, analytical development, and process development, in support of drug development projects. These activities may be performed by partners, contractors, or company personnel at various global locations, but mainly the US. The range of technologies used for products that he/she manage will vary from standard pharmaceutical dosage forms to parenteral injectables, sustained/controlled-release dosage forms, as well as drug-device combination products.
The appointee will be responsible for overseeing CMC activities on programs from early feasibility through process development, scale-up and registration at commercial scale. These programs are a mix of early-stage proof of concept, through IND, as well as late stage and life cycle management programs that require flawless execution because they are critical to commercial success. He/ She will also work with technical operations to support the transfer of these programs to commercial manufacturing.
- Responsible for CMC activities on assigned development programs.
- Specify the technical requirements for the development program, including performance criteria, control strategies, materials, analytical methods, test protocols, specifications, packages (clinical and commercial) and manufacturing methods.
- Manage remotely, ongoing technical programs at CMOs including developing detailed technical work plans; selecting suitable service for the various activities; managing the performance of the vendors.
- Facilitate and drive resolution of technical issues in a timely manner, driving action items and follow up.
- Ensure accurate tracking and reporting of project deliverables and milestones, maintaining consistent project documentation and preparing periodic updates for Sr. Mgmt.
- Prepare and author, in conjunction with Regulatory Affairs, the Chemistry and Manufacturing Controls sections of all regulatory filings for the products that they manage.
- Assist other department team members in reviewing documents on other projects (protocols, reports, regulatory filings, specifications, and the like).
- Support Technical Operations to ensure a smooth transfer of technologies and products into commercial manufacturing.
- Create intellectual property covering pharmaceuticals products.
- Drive Innovation and proof of concept activities.
- Communicate ideas and experimental designs for multiple projects with colleagues and managers; responsible for writing and presenting monthly, quarterly, and annual reports Additionally, author internal status reports and presentations to team and senior management on a regular basis.
- Monitor and communicate progress and budget and highlight delays or potential risks to project timelines.
- Higher degree in Chemistry (Organic Chemistry/Medicinal Chemistry) required, with 3 plus years of related industry experience.
- Extensive knowledge of pharmaceutical development.
- Experience with small molecule sterile parenteral and sustained release products would be preferable, along with drug product device combinations technologies (pre-filled syringes, autoinjectors, etc.)
- Broad exposure to multiple pharma technologies and knowledge of standard dosage forms.
- Experience working with and directing remotely contract manufacturing.
- Excellent communication skills and strong interpersonal skills.
- Demonstrated experience managing Contract Manufacturing Organizations.
- Knowledge of pharmaceutical QbD approach, ICH guidelines and US FDA process validation guidelines.
- Knowledge of medical device and/or combination products guidelines is an advantage.
- Teamwork – Balances team and individual responsibilities; Contributes to sustaining a positive team spirit; Puts success of team above own interests; Contributes positively to team morale and commitments to broader goals and objectives; actively participates in dialogue and expands understanding of goals.
- Problem Solving – Identifies and resolves problems in a timely manner, analyzing information skillfully; Develops alternative recommendations and solutions; Uses reason even when dealing with emotional topics.
- Interpersonal – Focuses on solving conflict, not blaming; Maintains confidentially; Listens to others without interrupting; Keeps emotions under control; Remains open to others’ ideas and tries new things; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; follows through on commitments.
- Leadership – Inspires and motivates others to perform well; Effectively influences actions and opinions of others; Inspires respect and trust; Accepts feedback from others; Contributes to vision, encourages, and inspires peers; Gives appropriate recognition to others.
- Business Acumen and Ownership – Considers business implications of recommendations and decisions, seeks input for same; Aligns work with strategic goals; Works within approved budge; Develops and implements cost saving measures; Conserves organizational resources.
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