Director Purification Process Sciences

Introduction to role:

Are you ready to lead a team that pushes the boundaries of science? Join us as the Director of Purification Process Sciences in Gaithersburg, MD, where your scientific expertise will directly impact patients' lives. At AstraZeneca, we are committed to delivering life-changing medicines through innovation and discovery. As a group leader within the Biopharmaceutical Development organization, you will provide both scientific and operational leadership, focusing on late-stage development, process characterization, and preparation of marketing applications. This is your chance to create a significant difference in a dynamic environment that values collaboration and top talent.

Accountabilities:

In this pivotal role, you will set the direction for a team of scientists dedicated to purification process development. You will craft and optimize downstream processes for manufacturing protein therapeutics, including monoclonal antibodies and antibody-drug conjugates. Your innovative approaches will drive continuous improvement in clinical and commercial manufacturing for biopharmaceuticals. As a spokesperson for Biopharmaceutical Development, you will connect with regulatory agencies, senior leadership, and R&D teams across therapeutic areas. Lead the purification development of multiple drug candidates from clinical development through registration, ensuring alignment with CMC teams and mentoring team members. Your expertise in preparing regulatory documents and understanding GMP and Quality issues will be crucial. You will oversee early and late-stage downstream development activities, ensuring delivery in a matrixed organization with sophisticated project plans. Represent Purification Process Sciences in communications with regulatory bodies and internal teams, authoring key documents and advancing scientific approaches through industry participation.

Essential Skills/Experience:

• Ph.D. or equivalent in chemistry/biochemistry, chemical/biochemical engineering, or related discipline, with 11+ years of proven experience with PhD (15+ years with BS/MS).

• Established expertise in a biopharmaceutical company in purification process development and tech transfer for biological products.

• Excellent oral and written communication skills are crucial.

• Confirmed ability to work effectively in cross-functional matrix organization.

• Prior supervisory experience is required (line management and/or matrix management). Experience as an effective leader and mentor for a diverse team of staff members.

• Demonstrated experience progressing biopharmaceutical products to licensure.

• Good solid understanding of drug development, including protein chemistry, protein purification, process design. Can solve problems through formal channels and informal networks. Work is performed with limited direction.

• Demonstrated leadership through project team participation, internal consulting and mentoring.

• Demonstrates ability to resolve conflicts between team members.

• Demonstrates the ability to effectively explain sophisticated scientific concepts to a broader, diverse audience. Frequent inter and intra-departmental collaborations. Has external alliances.

• Experienced with statistical design of experiments as well as identification of critical process parameters, in-process control limits, and scale-down model verification. Must be proficient in protein purification, including process chromatography, filtration, and process characterization.

• Encouraged to be knowledgeable in viral clearance, formulation, and product characterization/critical quality attributes

• Encouraged to analyze and interpret analytical and process data and understand the process and regulatory implications.

• Will be expected to effectively assess process capability and impact of process parameters and material attributes on product quality and process performance.

Desirable Skills/Experience:

• Demonstrated organizational and strategic leadership in establishing technical guidelines and business processes, as well as steering cross-organizational alignment within and outside of biologics CMC development.

• Deep understanding of regulatory requirements for development and commercialization of biopharmaceuticals.

• Team oriented and able to lead multiple projects across various development stages.

• Good understanding of quality systems and experience with successful internal and regulatory audits/inspections.

• Expertise/experience strongly desired in late-stage process development, preparation/review of BLAs/marketing authorization applications, technology transfer, and process validation.

• Good understanding of statistical design of experiments and the ICH concepts of quality by design, risk assessments, control strategy, and established conditions are strongly preferred, as well as principles of process validation from FDA/EMA guidances.

• Prior GMP experience is a plus. Able to prepare/review/approve documents such as development reports, tech transfer documents, validation protocols and reports, and regulatory submissions.

• Familiar with computer software including word processing, data evaluation, statistical packages.

• Familiar with protein purification equipment at laboratory and process scale.

• Demonstrated ability to lead cosophisticatedrojects. Experience with the application of modern approaches to development are highly desired, such as mechanistic modeling, prior knowledge, machine learning, and high efficiency laboratory development.

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.

The annual base pay (or hourly rate of compensation) for this position ranges from $171,426 to $257,140. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.  

At AstraZeneca, we are driven by our passion for science and our commitment to making a difference in patients' lives. We combine data and technology with scientific innovation to tackle some of the world's most complex diseases. Our inclusive environment fosters collaboration across academia, biotech, and industry to create impactful solutions swiftly. Here you'll find opportunities for lifelong learning as we push the boundaries of science with curiosity and courage.

Ready to make an impact? Apply now to join our team!

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 authorisation and employment eligibility verification requirements.