Associate
Director/Director, Bioanalytical and Drug Metabolism
Projects
The BDM Department is focused on developing bioanalytical
methodologies as in quantitative analysis of drug and
metabolite concentrations to support PK (bioavailability,
bioequivalence, drug interactions, dose proportionality
etc.), TK (different animal species and matrix), Medical
(special population) and Exploratory Pharmaceutics (in-vitro
models and in-vivo ADME) studies. In addition, this
department provides all the drug metabolism data for
the compound progression and submission that includes
mass balance, metabolite profiling, enzyme kinetics
(identification of enzyme systems involved in the biotransformation
of our development candidates, drug interaction evaluation
via inhibition/induction potentials). Currently, the
department has a total of 25 scientists including 9
Ph.D. and 16 MS/BS. The BDM department uses a project
matrix team approach, i.e. staff scientists are cross-trained
in multiple skills. They will work for projects on priority
basis rather than just for designated Ph.D. or technical
functions.
Reporting directly to the Executive Director are two
senior staff at the director/associate director levels.
One of the directors (Methodology & Metabolism)
is on board and he is responsible for developing and
validating bioassay methods to support projects, and
to develop methodologies for in-vitro and in-vivo metabolism
studies. This group has 5 Ph.D. with 2 additional openings.
This director also acts as deputy to the Executive Director
who is the Radiation Safety Office for FRI. These two
directors will complement each other in scientific knowledge,
leadership and project management skills, and act as
deputies to the department Head.
This Director/Associate Director opening will oversee
several BDM Lead Scientists (senior Ph.D.) who would
represent the department in project activities. These
BDM Lead Scientists are assigned responsibility of specific
compounds. In addition, two of the Lead Scientists have
supervisory responsibilities for 11 chemists.
BDM Lead Scientists will interact internally with the
Methodology & Metabolism group to develop the required
methods or to conduct the required in-vitro studies.
Externally, they will interact with scientists from
other R&D departments such as Clinical Pharmacology
& Drug Dynamics (responsible for all clinical PK
studies and submission documents), Pharmacology/Toxicology
(responsible for all TK studies, metabolites exposure
and submission documents), Exploratory Pharmaceutics
(BDM will provide bioassay supports for their in-vitro
permeability and pre-formulation studies) and PR&D
project management (resource planning and time line
tracking) to under what is required from BDM to support
compound progression and product development. The will
interact with Metrology and IT groups for instrument
calibrations, LIMS and electronic documentation. In
addition, they will interact with PR&D QA group
for compliance and if necessary with the Corporate Project
Teams and Regulatory department to address submission
issues. The BDM Lead Scientists are responsible for
the bioanalytical and drug metabolism summaries in IND
and NDA submissions. This position will provide administrative,
technical and regulatory guidance to the BDM Scientists.
This position will direct the BDM Lead Scientists in
project planning, resource allocation, negotiation of
priorities and time line, protocol design and review
and data interpretation.
We look for candidate with working experience in method
development: extraction techniques, chromatography and
instrumentation particularly with LC/MS/MS. This position
must have experience in small molecules (molecular weight
less than 500, i.e., not protein, peptides or macro-molecules).
Candidate must be familiar with the GLP, bioanalytical
method validation and run acceptance guidance as published
by FDA. The development pipeline is focused on some
early development and mostly late development phase
candidates; therefore, all bioanalytical data are subject
to QA audit. Candidate must have hands-on experience
in method development and validation. In addition, the
candidates should have a broad knowledge in product
development, PK and drug metabolism. Candidate should
have the ability to work in a project team environment,
have excellent oral and written communication skills,
and ability to negotiate priority and resources. Must
have ability to present and defend data. Good supervisory
and people skills are desirable.
This position, with qualifications and demonstrated
performance, will be administratively the Department
Deputy of the Executive Director.
Description of Duties and Responsibilities:
oCandidate will be supervising lead scientists to conduct
all phases of bioassays to support pharmacokinetics,
toxicokinetics and ADME studies.
oCandidate will accept study results, review study reports,
prepare position paper and submission documents, and
interacting with QA group.
oCandidate will also participate in reviewing method
development and validation, protocol design, evaluation
of literature data, study documents from research partners
and contract research organization.
oCandidate will assist Department Head in resource,
time line and budget planning. Candidate will supervise
senior level scientists and assist them in their career
development.
oThis senior position is also responsible for preparing
or reviewing relevant bioanalytical methods, data and
summaries for submission (IND and NDA).
oThis position is also responsible for summarizing metabolism
data from internal or external sources.
Qualifications:
oPh.D. degree in Bioanalytical Chemistry, Pharmaceutical
Science or related field with minimum 12+ years of bioanalytical/ADME
studies leadership experience in US pharmaceutical R&D
with at least 7+ years of supervisory experience with
Ph.D. level staff.
oExperience in product development phase activities
with some late discovery phase support is desirable.
oCandidate must have a good perspective of ADME issues
in drug development and regulatory submission.
oWill consider CRO experience with strong project management,
compliance, communication and people skills.
oCandidate must have hands on experience in bioanalysis
that include instrumentation (HPLC, LC/MS/MS and liquid
scintillation counting techniques), chromatography,
solution chemistry, extraction techniques (e.g. SPE),
automation (liquid handler, 96-well format), and electronic
LIMS (WATSON). Candidate should have direct working
experience in Good Laboratory Practices and regulatory
submission.
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Senior
Scientist Bioanalytical R&D
A CRO company located in the mid-west is seeking a Senior
Scientist Bioanalytical R&D to supervise laboratory
staff and manage laboratory operations. Monitors laboratory
workflows and processes and suggests and implements
changes to maximize quality, accuracy, timeliness, and
efficiency. Supervises method development activities
and troubleshoots problems arising during method development.
Stays aware of and advances the scientific understanding
of the work supervised.
Essential Duties and Responsibilities
oSupervise team leaders, scientists, and lab assistants.
oCoordinate method development/validation operations
to ensure timely completion of validation in accordance
with written protocols.
oAssign teams to complete projects.
oDevelop SOPs, forms, and processes to facilitate efficient
and high quality work.
oSupervise laboratory investigations and implement corrective
and preventative action as appropriate.
oMaintain a working knowledge of current good laboratory
practice regulations.
oAssist in a quality control role as needed.
oSet projects timelines and take action to ensure timely
completion of projects as needed
oTroubleshoot method development activities and direct
them as needed.
oReview the scientific literature and maintain of knowledge
of current practices and trends that are relevant to
the laboratory.
oUse knowledge gained from literature and conferences
to refine projects conduct procedures and to suggest
and help develop research activities for the laboratory.
oDesign, develop, engage in, and supervise research
projects and present the results of those projects at
pertinent scientific conferences.
oAbility to apply basic mathematical concepts necessary
to prepare reagents and dilutions, prepare standard
curves and quality control samples, and other relevant
routine laboratory tasks.
oA working knowledge of statistics
oA working knowledge of Watson LIMS
oAbility to identify, defines, and resolves problems
in a timely manner and understands the potential impact
of problems.
oPerforms all duties in accordance with SOPs, government
regulations and Good laboratory Practice.
oMay perform other duties as assigned.
Requirements:
oBachelor's degree the life sciences , chemistry or
equivalent in a related field of study and a minimum
of 8 years experience in Bioanalytical method development;
minimum of 4 years supervisory experience.
oDeals with concepts and complexity comfortably.
oMust be able to accurately determine length and difficulty
of tasks and projects; set objectives and goals; break
down work into the process steps; develop schedules
and task/people assignments; anticipate and adjust for
problems and roadblocks; measure performance against
goals; evaluate results.
oMust be able to manage multiple projects, project teams,
and to effectively communicate the status of projects
to respective clients.
oMust be willing to travel as appropriate.
oWorking knowledge of federal regulations, Good laboratory
Practice.
oProficiency in Microsoft Word, PowerPoint, Excel or
other similar database software.
oMust possess a customer service demeanor; must demonstrate
a strong sense of urgency, teamwork, keen attention
to detail, the ability to plan and organize and to multi-task.
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Associate
Director of Bioprocess Development
A pharmaceutical company located in New York is seeking
an Associate Director of Bioprocess Development who
will have the overall responsibility for the department
and its staff of approximately 20-25 scientific and
engineering professionals. Responsibilities include
oversight of technical groups responsible for the development
of biologics manufacturing processes. The Associate
Director, Bioprocess Development will report to the
Director of Biotechnology Development. He or she should
have solid demonstrated leadership qualities and be
results oriented. He or she will be an innovative, visionary
and strategic individual with a drive for continuous
improvement. Additional attributes desired include superior
intelligence, sound judgment, high energy, a strong
work ethic, flexibility, motivational and empowerment
skills and dedication.
Specific responsibilities will include providing tactical
and strategic oversight to the Bioprocess Development
group and leadership in the linkages with Quality Operations,
Bioprocess Engineering, Development Support, and Biotechnology
Operations. The Associate Director will also be responsible
for the recruiting, retention and development of talent
in the Bioprocess Development organization; the development
and alignment of objectives with partner organizations;
and maintaining relationships with internal and external
partners involved in Bioprocess Development projects.
Position Requirements:
The ideal candidate will have a Ph.D. in biochemical
engineering or a relevant biological science, strong
academic credentials, a solid history of technical accomplishments
with at least 5 years of industrial experience in biotechnology
and successful, demonstrated supervisory experience.
Specific qualifications desired include a demonstrated
knowledge of biologic manufacturing processes and process
science, and demonstrated skills in budget management.
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