Associate Director, MSAT

The posting

Job description

The Associate Director, MSAT is a recognised functional specialist, and will use expert scientific knowledge, technical skills and mature project management capability to enhance and shape the value proposition of Essential Pharma’s product portfolio. The Associate Director, MSAT will lead the strategy and delivery of technical transfers, select the right CMO partners and drive lifecycle improvements that maximise product value. Working with our contract partners, they will resolve manufacturing, quality and testing issues to ensure a resilient, continuous supply of vital medicines to patients. If you are keen to join a patient centric, high-growth company, then read on and apply today! Qualifications

• Required: Life Sciences degree in Pharmacy, Pharmaceutical Sciences or Chemistry.
• Desirable: Project management certification e.g. Agile, Prince2, PMP or other.

Experience

• Significant experience and proven track record of personally delivering successful site to site small molecule Tech Transfers including wide exposure to pharmaceutical manufacturing, analytics / QC testing, cleaning validation and packaging practices including serialization.
• Extensive experience across small molecule formats including sterile products, capsules, creams, gels, ointments and solid dose.
• Proven track record of successfully leading and delivering multiple complex site Tech Transfers, including cross-functional and multi-site programmes, with accountability for business outcomes
• Extensive, independent experience of manufacturing, registering and distributing pharmaceuticals across multiple regions, having led activity across several markets simultaneously. In depth experience of Quality Management Systems, including Change Control and Deviation management, leading Investigations, document creation, review and approval.
• Proven track record of independently leading and embedding continuous improvement programmes and lean management practices across multiple sites or functions.
• Proven track record of independently owning operational and programme-level budgets, including forecasting, risk-adjusted planning and spend governance across multiple projects. High levels of experience of successfully establishing and utilizing Technical Project Management tools and templates including timelines, trackers, Gap Analysis, risk registers, managing cross functional team meetings, charters and lessons learned.
• Demonstratable experience of managing financial/COGS implications when selecting CMOs. Including leading commercial negotiations and advising senior stakeholders on cost strategy.

Core Competencies

• Operates with full autonomy across the technical portfolio, setting direction for others.
• Possesses expert technical knowledge, applying deep subject matter expertise to shape decisions and influence outcomes.
• Strong Agile thinker who can adapt to situations of high-speed change.
• Problem solver who can work through complex issues and assimilate data from a wide range of scientific areas.
• Employee must demonstrate a Growth mindset and willingness to learn.
• Employee must demonstrate integrity and high ethical standards.
• Employee must have a dynamic and positive outlook. Actively demonstrating effective working as part of team with strong collaboration.
• Demonstrates a willingness to achieve goals together and respect the view of others.
• Results orientated and accountable for actions.
• Excellent organisational and time management skills with a keen eye to detail.
• Excellent communication skills, both written and spoken.
• An established and confident technical leader, freely provides coaching and positively influences business outcomes across borders and boundaries.
• Demonstrates strategic thinking in successfully delivering outcomes.

Tech Transfer and oversight

• As a recognised technical expert the MSAT Associate Director will work autonomously aligned with business goals and processes to successfully and personally deliver technically complex site to site transfers of manufacturing, analytical and packaging processes by providing critical know how and technical direction proactively managing and influencing key stakeholders to ensure successful outcomes.
• The MSAT Associate Director will be proficient in risk management and troubleshooting, proactively identifying and mitigating against technical challenges, proposing, championing and implementing robust solutions to resolve technical, scientific, compliance and Quality issues in conjunction with peers across various activities at CMO’s and CRO’s.
• Taking a structured approach towards centralised document control, proactively manage technical information, documentation and Quality records including MBRs, PQRs, validation protocols (process, analytics, cleaning, packaging etc), risk assessments, stability data, Change Controls and deviations maintaining the highest levels of compliance.
• Provide positive information exchange throughout the program lifecycle across various functional levels ensuring clear communication, real time visibility of progress and facilitating alignment with cross functional priorities and business goals. Includes project kick off meetings alongside Integration managers and other stakeholder functions. Ensures effective and timely handover management.

Technical Portfolio Management and Product Maintenance

• Leveraging their strong knowledge and technical know-how, the MSAT Associate Director will proactively review and enhance our product portfolio ensuring that A). CMO sites optimize our products and processes and B). our CDMO partner network is strategically aligned and beneficial, making sound recommendations to transfer out or consolidate products with alternative CMO sites where appropriate.
• Completing technical reviews and due diligence of target medicines identified by M&A for our potential acquisition initiatives. This technical assessment will include complexity of manufacturing, raw material challenges, transfer lead times, potential limitations or red flags and opportunities to enhance value.
• Providing technical expertise in answering questions relevant to CMC sections to achieve successful new site registration within compliance and agreed timelines and costs. Provision of technical/scientific advice to internal regulatory stakeholders if they must engage with the Regulatory Authorities addressing batch failures and/or specific variations (BSVs) and activities relevant to batch recalls.
• Providing specialist technical/scientific advice and recommendations to procurement and finance. Evaluate and assess one off costs including CAPEX as well as proposed CoGs when discussed with CMOs.
• Will proactively propose and lead the implementation of technical and business improvements through structured approaches ensuring continuous improvement of EPs practices, tools, systems and procedures.

Project leadership and management

• Taking a structured and data driven approach, coordinating development of project initial value blueprints (business model and case) aligned with business need and ensuring core drivers are tracked and met throughout project lifecycles. Ensuring timely handover of the business model.
• As a Project manager, the MSAT Associate Director will ensure that projects are planned, executed and delivered in a timely manner in alignment with business needs by defining scope, managing timelines, coordinating cross functional teams, establishing effective meeting structures and outputs as well as providing project management tools.
• Provide cross functional governance by establishing and monitor KPIs, developing and maintaining risk registers, tracking mitigation strategies, reporting adherence and controlling project costs by raising timely purchase orders, tracking spend and providing routine updates
• Will influence internal and external stakeholders, providing coaching, direction and real time impactful feedback ensuring adherence to best practice and eliciting positive business outcomes.

External operational partnership management

• Coordinate and manage the cross functional selection and evaluation of new CMO suppliers in collaboration with peers leveraging experience of financial/COGS implications when selecting CMOS.
• Support cross company governance by establishing relationships with key CMO partner Operations teams, building the necessary infrastructure to define rules of engagement such as joint project meeting series, escalation paths, project scope, KPIs, milestones and payment points aligned with technical delivery.
• Provide operational oversight, measuring and reporting performance.
• Act as the primary point of contact for operational project activities and ensure alignment between EP and CMO partners

Job benefits

What We Offer

• Competitive salary
• We understand that productivity requires balance, so we offer office-based contracts and allow flexibility on locations of work when required and appropriate. This can be different for each department so please have that conversation at interview
• Healthcare
• Pension – you contribute 5% and we offer 5%
• Life Insurance – lump sum (tax free) death benefit of 4 x basic salary
• Enhanced family leave
• Enhanced sick pay
• 25 days annual leave
• Discretionary annual performance bonus

What To Expect

• At Essential Pharma, every colleague matters: we want every member of the team to thrive and grow during their time with us
• Right from the interview stage, we encourage candidates to ask us questions, voice opinions and be curious
• This is a dynamic, fast-paced working environment. We expect individuals to be responsible and accountable, while understanding the importance of collaborating with colleagues to fuel success
• We pride ourselves on our inclusive culture, based on the belief that everyone brings unique strengths and perspectives
• We have an unwavering dedication to employee growth and development