Principal Scientist, Downstream Process Development
Allakos Inc. is a clinical-stage company developing therapeutic
antibodies for inhibitory receptors on the surface of immune
effector cells involved in allergic, inflammatory and proliferative
Allakos is committed to developing innovative therapies that
transform patients' lives. We are looking for bright and talented
individuals to join our team and share in our passion and
commitment to improving the lives of patients.
As a member of the Allakos team you will have the opportunity to
be a key member of the Biologics DS development and Tech Transfer
team and responsible for activities related to Downstream Process
Development of our late-stage clinical biologic (Mab) molecule
AK002 and other early-stage programs. This position will be
responsible for the Process Development, Tech Transfer, and
oversite of Engineering/Clinical batches at contract manufacturing
site/s. Additionally, there will be a strong focus on BLA-enabling
activities including process characterization, PPQ Batches and BLA
authoring and review.
* Provide technical leadership to the Downstream Process
Development group and technology transfer of AK002 process to CMO
sites. * Accountable for activities pertaining to the downstream
process development lab. Supervise planning and execution of
experiments. Analyze results and communicate them effectively to
management. * Coordinate with Upstream Development, Analytical, and
Facilities departments to successfully complete the DSP activities.
* Provide input for the strategy and experimental plan for
downstream process characterization studies. Generate protocols,
supervise execution, use statistical tools to analyze results, and
review reports for studies. * Assist in the planning of downstream
process development experiments for new molecules and supervise
execution of the same. * Supervise the Engineering and Clinical
batches at CMOs, review and approve Deviations and CAPA documents
for these batches. * Plan and supervise PPQ batches at CMOs. Review
and approve protocols and reports for PPQ batches. * Author BLA
submission documents. * Travel domestically and internationally up
to 10% of the time.
What We Value:
* At least 12 years of relevant experience (10+ with M.S., 8+
for Ph.D.) successfully working in the biopharmaceutical industry
with proven track record of leadership and success. * At least 5
years managing cross functional projects and leading teams. *
Extensive experience in Downstream Process Development and process
characterization of biologics, such as Mabs and fusion proteins. *
Strong background in statistical design of experiments (DoE) and
associated analysis * Experience in technology transfer and
facility fit assessments. * Should have worked with late and
commercial stage biologics, with experience in process development,
process characterization, PPQ batches, and other BLA enabling
studies and CPV programs. * Experience working with Contract
Manufacturers is preferred. * Experienced in BLA submission write
ups. * Experienced in people and stakeholder management, conflict
resolution, and building consensus. * Good understanding of
cGMP-regulations including relevant US/EU regulatory and quality
requirements, practices, and standards. * Exceptional interpersonal
skills to establish positive relationships with internal
stakeholders, CROs/CMOs, and multi-functional/multi-cultural teams.
* Ability to travel at least 10% of the time.
The Allakos Values are: Selflessness, Drive, Clarity,
Thoughtfulness, Fun, and Leadership.
Allakos is an equal opportunity employer. Allakos will consider
all qualified applicants for employment without discrimination on
grounds of disability, sex or sexual orientation, pregnancy or
maternity leave status, race or national or ethnic origin, age,
religion or belief, gender identity or re-assignment, marital or
civil partnership status, protected veteran status (if applicable)
or any other characteristic protected by law.