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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.

Job Spec

The Senior Manager, Drug Development will lead development projects run from Dublin. 
The activities may be performed by partners, contractors or company personnel at various global locations, but mainly the US. The role will focus on CMC activities, formulation development, analytical development and process development to ensure project success. 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.

Responsibilities

The Senior Manager, Drug Development will:

•    Lead 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 IND and NDA 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. 


Person Spec

•    The preferred candidate will have a strong relevant academic profile (Pharmaceutical sciences, Chemistry, Pharmacy, Process Engineering, Pharmacy) along with at least three years proven track record in leading pharmaceutical product development programs.
•    Alternatively, they will be qualified to PhD level (ideally in pharmaceutics, pharmacy, chemistry or chemical engineering) and will possess a strong insight into drug formulation and combination product development.
•    Direct experience of pharmaceutical development, QbD and target product profiling. Experience with sterile parenteral and sustained release products would be preferable, along with drug product device combinations technologies (pre-filled syringes, autoinjectors, etc)
•    Direct experience with authoring, reviewing and compilation of documentation for CMC regulatory filings for pharmaceutical products.
•    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.
•    Flexibility to travel on company business when required
•    A true self starter, who works effectively on their own initiative, and creativity in resolving technical issues.
•    Highly organised, with exceptional time management and prioritisation
•    Critical thinking/ evaluation of process problems
•    Strong work ethic.

 

Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
 

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce.  Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
 

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 .
 

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

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.