Pharmaceutical Manufacturing Development Specialist

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28 September 2020
DSTL
Location: Salisbury
Salary: £39,716 - £54,683
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Job Description

About the job

Summary

We are looking for a Pharmaceutical Manufacturing Development Specialist to join our small, lively, multifunctional team of pharmaceutical development employees and project managers where you will have responsibility for the oversight of provision of a number of Drug Substances and Drug Products across the lifecycle of the Dstl pharmaceutical product portfolio. This includes diverse products (primarily sterile parenterals) from small molecules to biologicals.

Youll be an integral part of an established research and development team which contains approximately 20+ staff with scientific, veterinary and clinical expertise and you will have responsibility for driving and taking ownership for pharmaceutical development manufacturing requirements, decisions and actions.

At Dstl, we protect lives; it means every aspect of our work has real purpose and the potential to be life-changing. To achieve the impossible, we bring together minds from around the globe to work across various fields. Its what makes us world leaders. With the freedom to work in a way that suits you, Dstl supports our people to come up with unusual and unexpected solutions. Solutions that simply cant be developed anywhere else.

If you are interested in this role but not sure if your skills and experience match our needs, please get in touch by emailing our recruitment team, dstlrecruitment@dstl.gov.uk and we can put you in touch with the pharmaceutical development team.

Job description

Dstl doesn't have a manufacturing capability in-house so these activities are procured externally. On a day-to-day basis you will work closely with Project Managers and project development teams in supporting the following range of activities:

- Developing manufacturing strategies and plans

- Providing specialist manufacturing advice to the project teams

- Handling Contract Manufacturing Organisations (CMOs) and external providers of manufacturing activities

- Reviewing manufacturing data including Batch Manufacturing Records (BMRs), analytical results, specifications etc.

- Supporting technical oversight visits and audits of CMOs and external providers of manufacturing activities

- Working with project teams to ensure Active Pharmaceutical Ingredients (APIs), Drug Substances and Drug Products are available to schedule to enable non-clinical and clinical studies

- Lead on the development of Statement of Requirements and Tender Assessments for subcontracted manufacturing activities

- Contribution to Regulatory Authority scientific advice meetings

- Contribution to regulatory documents (e.g. Investigator Brochures (IBs), Investigational Medicinal Product Dossiers (IMPDs), Clinical Trial Applications (CTAs), Common Techniocal Documents (CTDs) etc.)

- Take ownership and responsibility for delivering key manufacturing subcontracted activities

- Robustly lead subcontracted organisations

- Provide strong leadership in this specialist area

- Work efficient within a team environment to help ensure the achievement of project goals

- Communicate data to multi-functional teams

- Be proactive in identifying pharmaceutical manufacturing knowledge gaps

Responsibilities

You will need to have

- Experience in either pharmaceutical process development and/or formulation or analytical development relating to sterile parenteral products

- Proven evidence of applying regulatory requirements and mentors to pharmaceutical development projects

- Proven experience of developing successful manufacturing strategies and plans

- Proven experience of efficient leading subcontracted pharmaceutical manufacturing activities

- Demonstrable experience of working to cGMP

- Good IT Skills

Please see the attached role profile for further information about the role

If you are interested in this role but not sure if your skills and experience match our needs, please get in touch by emailing our recruitment team, dstlrecruitment@dstl.gov.uk and we can put you in touch with the pharmaceutical development team.

Behaviours

We'll assess you against these behaviours during the selection process:

Working Together

Making Effective Decisions

Delivering at Pace

Benefits

We'll provide a great range of benefits including;

Flexible working

Maternity, adoption or shared parental leave of up to 26 weeks full pay followed by 13 weeks statutory pay and a further 13 weeks unpaid, and paternity leave of 2 weeks full pay

Chartership and accreditation support

Pension

Generous annual leave

A competitive salary

Excellent learning and development

Onsite gyms and restaurants

Staff discounts for high street and online shopping, restaurants and days out.

Our Diversity Networks

Dstl recognises the importance of diversity and inclusion as people from diverse backgrounds bring fresh ideas. We are committed to building an inclusive working environment in which each employee fulfils their potential and maximises their contribution. We have a number of support networks to ensure all employees feel supported at work.

These include the following;

- Sexual Orientation and Gender Network

- Faith and Culture Network

- Parents and Carer Support Network

- Alternative Working Network

- Gender Equality Network

- New Starters Network

- Enabled Network

Please note that Dstl will be contacting individuals via email and you should check your junk mail folder regularly. Any attachments may not be available via smart phone or tablet views.

For further information about Dstl please check out our LinkedIn page 

Things you need to know

Security

Successful candidates must pass a disclosure and barring security check.

Successful candidates must meet the security requirements before they can be appointed. The level of security needed is security check.

People working with government assets must complete basic personnel security standard checks.

Selection process details

This vacancy is using Success Profiles, and will assess your Behaviours and Experience.

You will be required to provide an up to date CV along with your application, and then attend an interview at Porton Down if your application is successful. Please note that due to the current nationwide restrictions on gatherings and our social distancing measures at Dstl, interviews may take place via video interview. You'll receive further details via email should you be successful at the application stage.

PLEASE NOTE: Due to our status as a “Reserve Post” organisation, Dstl vacancies are open to candidates who only hold UK nationality.

If you hold Dual Nationality, i.e. have the right to abode, have citizenship or hold a passport/national identity card for another country outside the UK you will not be eligible for this role.

Important Information

The security of our work means that only UK nationals who have also resided in the UK for the last 5 years can be considered. Dual nationals cannot be considered for this rol.

Equal Opportunities

At Dstl we are committed to inclusivity and diversity within our workforce. During the application process we collect information to help us monitor this. It helps us better-understand our incoming workforce, as well as highlighting areas of improvement.

The information we request will not be used to make a decision about your application - no applicant or employee will ever be seen as more or less favourable based on disability, gender, martial or civil partnership status, age, ethnicity, sexual orientation or religion/belief.

Feedback will only be provided if you attend an interview or assessment.

Nationality requirements

Open to UK nationals only.

This job is not open to candidates who hold a dual nationality.

Working for the Civil Service

The Civil Service Code sets out the standards of behaviour expected of civil servants.

We recruit by merit on the basis of fair and open competition, as outlined in the Civil Service Commission's recruitment principles.

The Civil Service embraces diversity and promotes equal opportunities. As such, we run a Disability Confident Scheme (DCS) for candidates with disabilities who meet the minimum selection criteria.

Apply and further information

Contact point for applicants

Job contact :

Name : Dstl Recruitment Team

Email : dstlrecruitment@dstl.gov.uk

Telephone : 01980950000

 

Recruitment team :

Email : dstlrecruitment@dstl.gov.uk

Further information

Should you wish to raise a formal complaint about the Dstl recruitment process you should email dstlrecruitment@dstl.gov.uk stating the nature of the issue. We will respond within 5 working days.

Work Permit:

All applicants must be based in the UK and confirm that they are able to prove their eligibility to work in the UK.