Location: Deeside, Wales, UK
Department: Quality Control
Reference: VN798
Summary of the QC Manager role
Sterling currently has an exciting opportunity for a QC Manager to manage and lead the QC Department at our dedicated Anti-drug conjugate (ADC) centre of excellence at Deeside, North Wales.
Our team share one common goal, to transform the treatment of cancer and other infectious or chronic conditions. We are committed to ushering in a new era of cancer treatment, as well as the entry of this breakthrough technology into other therapeutic areas.
As the QC Manager you will lead the QC Department at Deeside and that includes personnel, equipment and facilities in the cGMP quality control function/laboratory to support the contract manufacture of parenteral protein-drug conjugate substances for pre-clinical, clinical and commercial use. This includes testing of raw materials, products, process intermediates, stability and environmental samples using a variety of chemical, bio-chemical and microbiological methods.
Sterling will support with relocation for the right candidate.
Sterling’s facility in Deeside site can be found lying alongside the waterways of the River Dee, presenting a quintessential glimpse of life in North Wales, with numerous nature parks, shopping centres and rural villages, providing plenty of opportunities to get out and explore. It’s just a short journey from the cities of Chester, Liverpool and Manchester or you can choose to go a little further afield and from the mountains of Snowdonia to the all Wales coastal path, walking is a dream in North Wales.
Who Are We?
We are a fast-growing global pharmaceutical CDMO (Contract Development and Manufacturing Organisation), with more than 50 years’ experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs). We are a proven and trusted partner to some of the world’s most innovative biotechs and leading pharmaceutical companies and are widely recognised for our expertise in complex and hazardous chemistry.
We are a dynamic business, employing more than 1300 talented and passionate people in the UK, US and Europe who together support our customers in bringing new medicines to market, improving and saving the lives of patients. We support our customers through the full product lifecycle from pre-clinical development right up to full scale commercial manufacturing and today we are proud to have built a culture of excellence in science and unrivalled service.
Your responsibilities
Requirements for the role
Why Consider Us?
Our collaborative and empowering culture is unique to us and is what really sets us apart as a business and this is built upon our four core values: Be Transparent, Be Reliable, Be Willing and Be Caring. We also run a variety of programmes across our sites to promote health, wellbeing and work life balance, in addition to supporting causes and charities close to our employees’ hearts, encouraging volunteering within the communities we are part of and even arranging socials, through our global social committees, to encourage team building and reward our team’s hard work.
At Sterling we promote mutual trust and respect regardless of your nationality, background, feelings, beliefs, gender or age. Our workforce, much like life, is made up of many different people with many different backgrounds, needs and perspectives. This is something we celebrate at Sterling, as it makes Sterling a better place to work and encourages innovation and collaboration.
We offer a competitive compensation and benefits package including bonus, pension scheme, private healthcare, Engagement Hub, cycle to work scheme, death in service coverage, on-site health and wellbeing support including medical consultations and physiotherapy, 24/7 employee assistance programme, employee referral scheme, sports and social club as well as opportunity for training and further career development.
Sterling currently has an exciting opportunity for a QC Manager to manage and lead the QC Department at our dedicated Anti-drug conjugate (ADC) centre of excellence at Deeside, North Wales.
Our team share one common goal, to transform the treatment of cancer and other infectious or chronic conditions. We are committed to ushering in a new era of cancer treatment, as well as the entry of this breakthrough technology into other therapeutic areas.
As the QC Manager you will lead the QC Department at Deeside and that includes personnel, equipment and facilities in the cGMP quality control function/laboratory to support the contract manufacture of parenteral protein-drug conjugate substances for pre-clinical, clinical and commercial use. This includes testing of raw materials, products, process intermediates, stability and environmental samples using a variety of chemical, bio-chemical and microbiological methods.
Sterling will support with relocation for the right candidate.
Sterling’s facility in Deeside site can be found lying alongside the waterways of the River Dee, presenting a quintessential glimpse of life in North Wales, with numerous nature parks, shopping centres and rural villages, providing plenty of opportunities to get out and explore. It’s just a short journey from the cities of Chester, Liverpool and Manchester or you can choose to go a little further afield and from the mountains of Snowdonia to the all Wales coastal path, walking is a dream in North Wales.
Who Are We?
We are a fast-growing global pharmaceutical CDMO (Contract Development and Manufacturing Organisation), with more than 50 years’ experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs). We are a proven and trusted partner to some of the world’s most innovative biotechs and leading pharmaceutical companies and are widely recognised for our expertise in complex and hazardous chemistry.
We are a dynamic business, employing more than 1300 talented and passionate people in the UK, US and Europe who together support our customers in bringing new medicines to market, improving and saving the lives of patients. We support our customers through the full product lifecycle from pre-clinical development right up to full scale commercial manufacturing and today we are proud to have built a culture of excellence in science and unrivalled service.
Your responsibilities
- Leading and managing the multifunctional QC team of 16+ analysts ensuring compliant and effective training and development.
- Budgetary responsibility for the QC Department including management of spend and equipment capital expenditure ensuring development and testing service is provided in a cost-effective manner whilst meeting key milestone deliveries.
- Working with the project and business development managers from receipt of RFPS to develop firm proposals and subsequent project delivery.
- Maintaining and expanding the cGMP QC services which encompasses chemical, biochemical, cell biology and microbiology analyses.
- Defining all equipment requirements, procuring, and qualifying new equipment and maintaining them in a state of compliance; URS, DQ, IQ, PPM programs.
- Creating, reviewing, and approving all necessary documentation including but not limited to analytical methods, raw material and product specifications, certificates of testing, stability study protocols, method qualification protocols and reports.
- Managing the ongoing environmental monitoring and water testing of the GMP facility and operation.
- Managing the investigation of out of trend, out of specification and any deviations events.
- Ensuring that all regulatory expectations are met regarding any GMP QC samples or data collected, manipulated, reported, stored or archived.
- Providing timely and accurate testing updates for materials, samples, products and stability studies to internal parties and external clients.
- Embodying our company values; Be Transparent, Be Willing, Be Reliable and Be Caring.
- Degree (or preferably Masters/PhD) or equivalent in Chemistry/Biochemistry or a related scientific/technical field.
- Previous supervisory/management experience within a cGMP QC laboratory.
- Knowledge/experience of testing protein therapeutics (ideally antibody drug conjugates).
- Expertise in chemical, biochemical and microbiological method development, qualification, and statistical quality control.
- Excellent knowledge of cGMP and their variation across the major global territories; MHRA, EMEA, FDA, MHLW, ANVISA, Health Canada etc.
- Excellent knowledge of regulations and guidance’s provided by globally recognised parties and guidelines; laboratory cGMP, ICH, USP, EP, JP etc particularly as related to analytical method development and validation.
- Excellent verbal and written communication skills, experience with scientific writing including authoring and revising SOP’s and technical reports.
- Used to working in a fast-paced complex environment, able to work to flexible schedules.
- Experience in working with highly potent samples and associated containment and safe working practices.
- Experience of supporting regulatory and client audits.
- Must align to our company values; Be Transparent, Be Willing, Be Reliable and Be Caring.
Our collaborative and empowering culture is unique to us and is what really sets us apart as a business and this is built upon our four core values: Be Transparent, Be Reliable, Be Willing and Be Caring. We also run a variety of programmes across our sites to promote health, wellbeing and work life balance, in addition to supporting causes and charities close to our employees’ hearts, encouraging volunteering within the communities we are part of and even arranging socials, through our global social committees, to encourage team building and reward our team’s hard work.
At Sterling we promote mutual trust and respect regardless of your nationality, background, feelings, beliefs, gender or age. Our workforce, much like life, is made up of many different people with many different backgrounds, needs and perspectives. This is something we celebrate at Sterling, as it makes Sterling a better place to work and encourages innovation and collaboration.
We offer a competitive compensation and benefits package including bonus, pension scheme, private healthcare, Engagement Hub, cycle to work scheme, death in service coverage, on-site health and wellbeing support including medical consultations and physiotherapy, 24/7 employee assistance programme, employee referral scheme, sports and social club as well as opportunity for training and further career development.
Be caring. Be transparent. Be willing. Be reliable.
