Senior Development Associate/Associate Scientist
This position is in the Analytical Sciences Group within Process
Development. This group is responsible for performing in-process impurity
and product characterization assays. This group supports the development
activities of the cell culture and the downstream groups within Process
Development.
Responsibilities:
The Senior Development Associate/Associate Scientist will be responsible
for optimization, qualification and transfer of the test methods to support
in-process analytical testing of recombinant biopharmaceutical antibody
products. He or she is also responsible for doing routine assays to support
the development activities of the cell culture and purification groups. In
addition to these, he or she is expected to prepare standard operating
procedures (SOP), summaries, tables and technical reports as well as
present data internally and externally. Troubleshooting test methods
and analyzing and interpreting data while applying sound scientific
principles is an integral part of this job.
Interaction:
There will be significant cross-departmental interactions for this
position, especially with the Quality Control (QC) department within
Genmab. Interactions involve obtaining or providing information as
well as collaborating on projects. Excellent interpersonal skills,
the ability to work in a fast-paced and sometimes stressful environment
independently or as a team member is required.
Leadership/Management:
The person should be able to provide guidance and be willing to be a mentor
for the junior level staff within the department. Ability to provide
scientific leadership on matters pertaining to analytical assays is
expected. The managerial experience required to perform this job is
limited, however, the candidate is expected to show the potential to assume
managerial and leadership positions in the event of an expansion of this
group in the future.
Experience/Education:
Test method implementation, qualification and troubleshooting experience
with High Performance Liquid Chromatography (HPLC) and electrophoretic
methodologies. Experience with Enzyme Linked Immunoadsorbent Assays
(ELISAs) and with qualifying test methods per FDA and ICH guidelines is a
must. He or she should be consistently detail-oriented and have excellent
analytical and communication skills. Be able to prioritize multiple tasks
and concurrent projects. Should have a good knowledge and understanding of
the best industry practices for the analytical assays.
BS in Physical or Life Sciences with a minimum of 8 years of directly
related experience or a MS/MA in Physical or Life Sciences with a minimum
of 6 years of directly related experience and proven scientific ability.
Familiarity with cGMP and GLP and applicable regulatory guidelines is
preferred.