Global Technical Operations, Director, Conjugates at AstraZeneca in Gaithersburg, Maryland

Posted in Other 13 days ago.

Job Description:

Global Technical Operations, Director, Conjugates- Gaithersburg, MD

The GTO New Modalities and Technology Director role was created as a multi-functional leadership position representing Biologics Operations on key early leadership teams with the primary responsibility for strategic planning and coordination of technical leadership and support from the Operations global technical network to key customers across the enterprise. This role will specifically lead the Operations early technical strategy for conjugates and conjugated resin platforms. This includes the responsibility to act as the technical lead in Operations for the establishment of biologics conjugates platforms, including antibody drug conjugates and radio conjugates, as well as collaborating with our Biopharmaceutical development unit to define the platform used to purify these conjugates.

About the team:

The New Modalities team work with the Biologics Development to take on new, unique and different biologic medicines including: Cell Therapies (pluripotent/regenerative, autologous, and Immune cell based), Viral Therapies (Gene therapy and oncolytic), Nucleic Acid therapies (e.g. mRNA, saRNA), Antibody Conjugates ( ADCs, Radio Conjugates), and other pipeline biologics.


Acting as early MS&T for Conjugates, lead Operations engagement with development technical and leadership teams, including, but not limited to: Global Enterprise, Franchise and multi-product business units, CMC and clinical strategy teams, CMC platform teams, Pharmaceutical Development leadership teams, Operations leadership, including External Sourcing, Global Supply and Strategy, and Biologics Leadership. Establish and lead Operations standard work including the following, while working collaboratively in a Matrix Environment: Validation strategies, Change management strategies, including Comparability and "Switch" Strategies, Technology transfer to internal and external assets, Design of facilities for use in manufacturing conjugated biologics, Process standardization and cost reduction efforts. Drive harmonized processes for selecting and updating platforms for conjugation, including antibody drug conjugates, radioisotope conjugates, and resins. Act as the Subject Matter Expert and process engineer role for site engineering efforts to retrofit or construct capabilities. Establish and lead a technical network of key influencers and decision-makers to evaluate and propose new technologies and processes to prepare Operations for New Modalities. As network sites are established, working with the site, establish tech transfer and site technical business processes, in addition to a talent pipeline. Consult on aseptic fill, formulation and lyophilization development, process design and validation. Co-ordinate partnership of GTO team with Regulatory, Quality Assurance, and CMC teams to support writing the technical content of regulatory filings and ensure flexibilities are built in to minimize impact of future changes. For virtual sites in network, ensure that full scope of MS&T support is provided to Virtual site for tech transfer and commercial manufacturing for all products and sites (CMOs and OTLs), working with the existing GTO teams. These responsibilities include: Ensure timely and efficient communication between GTO technical team internally and externally with CMOs. Oversee the technical accountability and responsibilities for virtual site are met by using the GTO matrix organization. Communicate technical concerns/risks/issues to the GTO and Biologics leadership team, as appropriate. Escalation of technical risks/issues and resource needs. Alignment of bio-operations technical strategies, Score-card updates, business planning and financial updates. Ensure technical capability builds can support product portfolio and bio enterprise strategy align priorities of CMC technical teams and Biologics Operations. Provide guidance and leadership on alignment of business processes and ways of working.

Essential Skills/Experience:

- Extensive knowledge of critically relevant areas such as analytical characterization, formulation, and the general CMC scope for ADC biologics.
- Experience in a Commercial/late stage manufacturing setting
- Proven history of regulatory document authoring or regulatory technical strategy development
- Bachelor of Science with 13+ Years of experience in biologics manufacturing; 10+ years with advanced degree
- The ability to co-create and collaborate in complex and agile environments
- Ability to advance projects against accelerated timelines, clearly define go/no go decisions points, with a focus on execution.
- Experience with Project Management (budgeting, timelines, resourcing, planning).
- Excellent communication skills, highly effective in interacting with key internal and external partners.
- Strong organizational and coaching skills.

Desirable Skills/Experience:

- Late phase/commercial experience in resin evaluation, selection and platformization, including resin selection experimental design
- Facility engineering, commissioning and qualification experience
- Aseptic fill finish characterization and validation
- Lyophilization characterization and validation experience
- Demonstrated leadership in expedited yet thorough evaluation of emerging technology
- Ability in influence and balance the interests of multiple collaborators while ensuring results
- Proficiency with PowerBI, PowerAutomate and Microsoft Office suite of tools
- Understanding and competency in DoE study design

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca?

Be part of shaping the future of Operations here at AstraZeneca. Be part of shaping the next phase of Operations' journey towards the 2025 strategy. Build on our foundations of high performance through agility, responsiveness, reliability and efficiency to deliver our new modalities and sophisticated pipeline to market at speed. Backed by a supportive team, be part of accelerating our operational excellence with innovations in innovative science, Lean ways of working and constantly evolving digital technologies.

Make a positive impact, in a team where it means more. In Operations, we have a big ambition: to deliver more medicines to patients, quicker and more affordably. Backed by the investment, leadership and a clear plan to get there, we bring personal dedication and out of the box thinking. We are driven by our commitment to deliver accelerated growth for AstraZeneca and to make people's lives better. It pushes us to keep building on our foundations and progressing as we turn our ever-growing and increasingly complex pipeline from molecule to medicine. Be part of evolving how we work with Lean, pioneering science, digitalisation and sustainable practices.

Are you ready to make a difference? Apply today and join us in our mission to create life-changing medicines!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

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