Sr. Manager, Drug Development

Location: 

Dublin, IE

 

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

I: Job Summary
The 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. This position reports to the Director, Drug Development sitting in Dublin.

 

II: Responsibilities (Include key responsibilities only. This should not be an all-encompassing list)
•    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. 

The above statements are intended to describe the general nature of work performed by those in this job.  It is not an exhaustive list of all duties, and other duties may be assigned.

 

III: BEHAVIORS
To perform the job successfully, an individual should demonstrate the following competencies:
•    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.

IV: Education, Experience & Skills

•    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.


 

 

As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements and an extensive benefits package. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.