- Develop and implement a comprehensive strategy for the manufacturing technical operations unit, aligning with the company's overall vision and goals
- Responsible for the manufacturing process lifecycle and continuous process verification program for small and large molecules.
- Responsible for timely execution of technology transfer projects and process improvement projects
- Responsible for supporting projects through the preparation and/or review of documents such as protocols, reports, master batch records, investigation reports, etc.
- Lead teams on troubleshooting and data analysis to solve technical problems in manufacturing to ensure manufacturing output and product quality are maintained.
- Support and lead risk assessments and manufacturing deviation investigations
- Work closely with other departments, including CMC, quality assurance and Global Regulatory Affairs, to ensure cohesive and integrated operational strategies.
- Collaborate with the CMO senior leadership teams to ensure any areas of conflict get resolved in a timely manner and escalate to senior management as appropriate if required Identify and mitigate risks associated with manufacturing operations, proactively implementing strategies to prevent deviations and ensure continuous improvement.
- Drive initiatives for process optimization, technology implementation and best practices to improve manufacturing operations.
- Foster strong relationships with internal and external stakeholders, ensuring alignment of manufacturing technical operation strategies with CMO and organizational goals.
- 15+ years experience in pharmaceutical and/or biopharmaceutical manufacturing of drug substance, with a strong understanding of GMP and regulatory compliance.
- Excellent communication, negotiation, and CMO management abilities.
- Strong problem-solving skills and a proactive approach to driving continuous improvement in manufacturing processes.
- CAPA implementation and CAPA effectiveness review.
- Experience with continuous manufacturing; Knowledge of batch record development and management for drug substance manufacturing.
- Knowledge of lean manufacturing principles.
- Hands on cell culture experience with cGMP commercial manufacturing
- Familiarity with perfusion bioreactor systems coupled with ATF and other harvesting technologies, Unicorn chromatography control system and Delta V.
- Knowledge of cGMP manufacturing of recombinant enzymes.
- Travel to CMO's may be required to meet business needs. 10% travel.
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Credit Risk Manager
4 hours ago
Willow Resourcing Birmingham, United Kingdom**Credit Risk Manager** · **Innovative Mortgage Lender** · **Location: Remote (UK)** · **Isn't it time you joined a Mortgage business as ambitious as you are?** · This is an opportunity to take your Credit Risk career on to the next level with an innovative mortgage lender that's ...
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Risk Analyst/risk Manager
1 day ago
eFinancialCareers Rugby, United KingdomResponsibilities Include: · - Recognise areas where infrastructure can be improved and participate in the implementation of improvements. · - Oversee model performance tests and assess the appropriateness of models to display adherence · - Construct and preserve risk reports to t ...
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Risk Management System Administrator
4 hours ago
Birmingham Women's and Children's NHS Foundation Trust Birmingham, United KingdomThe Quality Governance Team is looking for a hardworking and motivated person to join a well-established team as a Risk Management System administrator (currently Datix). This is a good opportunity for somebody with experience working in an administrative risk and quality governa ...
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Head of Risk and Risk Management
2 days ago
Hunter Mason Consulting Ltd Solihull, West Midlands, United KingdomOur client is actively seeking an accomplished professional to assume the pivotal position of Principal Flood Risk Management Specialist. This role demands a seasoned expert capable of providing strategic leadership and innovative solutions in flood risk management. Orchestrating ...
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Principal Flood Risk Management Specialist
4 days ago
Hunter Mason Consulting Birmingham, United Kingdom Full timeTHE ROLE · Our client is actively seeking an accomplished professional to assume the pivotal position of Principal Flood Risk Management Specialist. This role demands a seasoned expert capable of providing strategic leadership and innovative solutions in flood risk management. Th ...
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Risk and Business Continuity Manager
6 days ago
Correla Solihull, West Midlands, United KingdomYour role isto lead our Risk and Business Continuity function across the organisation as we grow and expand. · Salary c£60,000-£65,000 (depending on experience) plus bonus and generous benefits including uncapped holidays, Private Medical Insurance and informal flexible agile wo ...
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Risk Manager
1 hour ago
Arcadis Birmingham, United Kingdom UndefinedArcadis is the world's leading company delivering sustainable design, engineering, and consultancy solutions for natural and built assets. · We are more than 36,000 people, in over 70 countries, dedicated to improving quality of life. Everyone has an important role to play. With ...
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Risk Manager
1 day ago
Balfour Beatty- Vinci Birmingham, United KingdomRisk Manager · Are you looking to progress your career by working on Britain's biggest construction project? · Balfour Beatty VINCI is working with a range of organisations to design and build 90km West Midlands stretch of HS2 - Britain's new high speed railway.. · Our work is es ...
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Risk Manager
6 days ago
Turner & Townsend Birmingham, United KingdomThat means delivering better outcomes for our clients, helping our people to realize their potential, and doing our part to create a prosperous society. · Every day we help our major global clients deliver ambitious and highly technical projects, in over 130 countries worldwide. ...
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Risk Manager
1 day ago
Energy Jobline CVL Birmingham, United KingdomRisk Manager · Are you looking to progress your career by working on Britain's biggest construction project? · Balfour Beatty VINCI is working with a range of organisations to design and build 90km West Midlands stretch of HS2 - Britain's new high speed railway.. · Our work is ...
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Risk Manager
6 days ago
Turner & Townsend Group Birmingham, United KingdomThat means delivering better outcomes for our clients, helping our people to realize their potential, and doing our part to create a prosperous society. · Every day we help our major global clients deliver ambitious and highly technical projects, in over 130 countries worldwide. ...
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Risk Manager
6 days ago
Turner & Townsend Birmingham, United KingdomThis job is brought to you by Jobs/Redefined, the UK's leading over-50s age inclusive jobs board. · Company Description · At Turner & Townsend we're passionate about making the difference. That means delivering better outcomes for our clients, helping our people to realize thei ...
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Risk Management
5 days ago
Randstad Staffing Birmingham, United KingdomPosition: Project Manager (clean & waste water treatment) · A leading tier 1 with a designated arm dedicated to providing innovative solutions in the water treatment industry. With a strong commitment to sustainability and environmental stewardship, they specialise in designing, ...
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Risk Management Surveyor
1 day ago
HSB Birmingham, United KingdomRole: Risk Management Surveyor · Location: Birmingham/Coventry · Department: MD Warranty Inspection Services (MDWIS) · Permanent · Job Purpose: · To provide site inspection and technical building and construction expertise relating to the risk management of construction s ...
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Operational Risk Manager
1 day ago
ZEN Birmingham, United KingdomWe're inviting you to work together on a tool that will help customers from all over the world manage their money with zero effort. Join the ZEN team now and change the world of finance for the better. At ZEN you'll get to work with a lot of exciting new technology. · We're looki ...
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Resilience and Risk Management Manager
4 days ago
MERJE Ltd Birmingham, United KingdomThis role sits within the AXA Commercial Risk Team, a first line risk function fully embedded in the business. The role will bring expertise and knowledge to support, direct and influence the Commercial business' senior managers and their teams in embedding use of the AXA UK ente ...
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Mortgage Quality Assessor Hybrid
22 hours ago
Acorn by Synergie Solihull, United Kingdom Full timeAcorn by Synergie are recruiting for an exciting permanent opportunity to work for a mortgage broking company in the B37 area of Solihull. · * Permanent from day one · * Paying £28,000 per annum plus several opportunities to progress within the business to increase salary · Th ...
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Enterprise Risk Manager
3 hours ago
AXA Group Birmingham, United Kingdom Full timeOur AXA Commercial Risk team are a first line risk function fully embedded in the business. As Enterprise Risk Manager, your expertise and knowledge will support, direct and influence the Commercial business' senior managers and their teams. You'll embed the use of the AXA UK ent ...
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Executive Assistant
4 hours ago
RecFlex Solihull, United Kingdom**Job Title**: Executive Assistant · **Salary**: £45,000 to £50,000 · **Location**: Solihull · **Hours**: Full time, Monday to Friday (hybrid) · **Hybrid working** is available for all employees and can be tailored to suit the individual. This company is renowned for employee ret ...
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VP, Risk Management
1 week ago
Goldman Sachs Birmingham, United KingdomThe Goldman Sachs Group, Inc. is a leading global financial services firm providing investment banking, securities and investment management services to a substantial and diversified client base that includes corporations, financial institutions, governments and high-net-worth in ...
Director, Quality and Risk Management - Solihull, West Midlands, United Kingdom - RPMGlobal
Description
Senior Director Manufacturing Technical Operations Location Ireland Requisition ID 2228 # of openings 1Senior Director Manufacturing Technical Operations
Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering high-quality medicines for people living with rare metabolic diseases.
The Senior Director of Manufacturing Technical Operations will lead the manufacturing technical team in support of the oversight and management of Amicus external manufacturing network.
This role requires a strategic leader with a strong background in biopharma/pharma manufacturing, regulatory compliance, and quality focus.Lead and manage the manufacturing technical operations team supporting commercial manufacturing activities and late-stage development activities.
Professional Work Experience Requirements
We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
Employee expertise, intelligence, and creativity drives our innovation, and our passion and commitment to excellence.Amicus is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability, sexual orientation, gender identity, protected veteran, disability status or any other characteristics protected by applicable federal, state or local law.
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Director, Quality and Risk Management professionals in Solihull
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Ben Crumpton
International Management Accountant
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Diane Booth
Award Winning Sustainability Director