Study Manager BCD

We are looking for:

Study Manager BCD

To study direct/analytical project mange a range of Metabolism studies (e.g. clinical metabolism mass balance, ADME, Biologics, dermal penetration) for new product development based on global regulatory requirements.

At Pharmaron we offer:

• Vibrant and dynamic employment –we are a highly specialised, growth company operating in a critical sector of the economy – our future is strong and exciting!
• Opportunities to develop your skills and yourself –our rapid growth brings greater opportunities for you to learn and grow faster!
• A great team where we all support each other –enjoy your work – after all you spend about a third of your time here!

Requirements:

• PhD, MSc or BSc (Hons) in Chemistry, Biochemistry , Biomedical Sciences or related subject

• Experience of working in Metabolism laboratory

• Experience of working with Radioactivity (14C /3H)

• Experience of Study Directing in a GLP/GCP facility

Key roles and responsibilities:

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  Act as Study Director, Analytical Project Manager and/or Principal Investigator on a range of Metabolism studies (e.g. clinical metabolism mass balance, ADME, Biologics, dermal penetration) studies.
• Take full responsibility for the conduct of experimental work required to successfully fulfil all the requirements of a study to the timelines stated in the Study Plan.
• Plan work to ensure revenue recognition milestones on assigned studies are hit in the month, flagging up any issues early. Ensure resource allocated to their studies is effectively utilised.
• Prepare study plans, amendments, file notes and deviations as required.
• Prepare worksheets to coordinate experimental activities.
• Calculate and QC check data.
• Review data obtained and prepare study updates and study data for discussion internally and for communication to the client/inclusion into reports.
• Prepare study reports.
• Address findings arising from QA audits and process inspections.
• Effectively communicate with clients regarding study progress and address client comments.
• Supervise, mentor and/or train more junior members of staff.
• Review cost builds for assigned studies with Team Leader, track actual vs budgeted hours providing feedback where changes to cost builds are necessary. Ensure any potential work scope changes are flagged to management.
• Increase profile of the department externally by publishing papers/posters and participation in expert groups.

Our Company:“We are a dynamic, fast-growing company, with an enviable reputation for leading edge science, offering contract research services to some of the world’s leading pharmaceutical companies, solving what were believed to be unsolvable scientific challenges”.

We believe in our ability to relentlessly push forward the boundaries of scientific excellence, delivering solutions for our clients, always operating ethically and with integrity. We take pride in our professionalism and commitment to always deliver our very best work.

Based in Northamptonshire, our Rushden site is a centre of excellence for Radiolabelled Sciences incorporating both Metabolism (which includes Clinical Metabolism, Pre-clinical ADME, In vitro and DDI services, Large Molecule Metabolism, Environmental Fate, Plant Metabolism and Metabolite Identification) in addition to Chemistry (which includes API and IMP manufacture). We offer our employees a supportive teamwork environment, enabling them to develop and liberate their true potential.

• 
  We offer a competitive salary and a progressive and comprehensive suite of employee benefits.
• We offer state of the art working environment in our specialist Rushen site.
• We offer the opportunity for growth and development and will support funding for relevant training and development programmes.

Why Should You Apply?

• This is an opportunity for you as a Study Manager BCD professional to make a real impact in a highly scientific and regulated environment, demonstrate leadership, ambition and the desire to grow with the department.
• Build and shape your career in an environment that sets and commits to the highest standards of Chemistry.
• To be part of a team who support each other, embrace and solve technical challenges and put excellence at the heart of all that we do.

Pharmaron is a premier R&D service company supporting the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities having established diverse drug R&D service capabilities, ranging from synthetic, medicinal, and analytical chemistry, biology, DMPK, pharmacology, drug safety assessment, radiochemistry and isotopically labelled metabolism, chemical & pharmaceutical development to clinical development. With operations in China, US and UK staffed by over 19,000 employees, Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan, and China.