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Lead cross-functional efforts in the research, design and execution of scientific studies to enable the drug product (DP) formulation and process development, characterization, commercial validation and regulatory filing of parenteral/injectable biologic products. Lead the development of early and late stage formulation development efforts and a variety of manufacturing unit operations including, drug substance (DS) freeze/thaw, compounding/mixing, sterile filtration, drug product filling of vials/syringes, visual inspection, and DS/DP transportation. Hands on experience with bio-therapeutics drug product development, including a detailed understanding of the manufacturing unit operations is required. An understanding of protein chemistry, formulation, and biopharmaceutical assay (e.g. HPLC, CE, iCE, HIAC, MFI, etc.) development as well as the ability to run biopharmaceutical assays in a laboratory is needed. Experience in interactions with clinical teams, designing in-use compatibility studies and extractables and leachable studies is preferred.
Lead a team of associate scientists, managerial and regulatory filing experience. Involved in regulatory filing and in reviewing technical reports for early and late stage programs. Attention to detail for data review/trends and working in a fast paced multifaceted environment is expected with ability to prioritize for team and self is needed.
In addition, the candidate will provide clinical and commercial manufacturing site support including but not limited to weekly/biweekly support meetings, action item owner, and as necessary in-person on-site manufacturing support. This position is encouraged to interact regularly with cross-functional staff from Analytical Sciences, Clinical Operations, Quality Control, Drug Substance Process Development, Manufacturing Technical Services, Quality Assurance, and/or CMC Regulatory Affairs.
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Expectation of working in the office 4 days a week statement: When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of four 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.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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.
Other
Pharmaceutical
$145k-178k (estimate)
03/24/2024
06/29/2024
alexion.com
BOSTON, MA
3,000 - 7,500
1992
Public
LUDWIG N HANTSON
$5B - $10B
Pharmaceutical
Alexion develops and commercializes immunoregulatory drugs for the treatment of autoimmune and cardiovascular diseases.