P2410 - Senior Scientist, Analytical Development and Quality Control
Jobbeschreibung
Lausanne, Waadt, Schweiz
Debiopharm
03.05.2024
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DescriptionDebiopharm is privately-owned Swiss biopharmaceutical
company commitmented to research in oncology and infectious diseases
in order to improve patient outcomes and quality of life. Debiopharm
International SA aims to develop innovative therapies via our unique
“development only” business model, acting as a bridge between
disruptive discovery products and patient access in international
markets. At Debiopharm you will be at the forefront of the fight
against cancer and infectious diseases through working on innovative
medicines for patients. Join our team at Debiopharm where together, we
innovate, we impact, and we grow.For our Pharmaceutical Development
organization based at our Headquarters in Lausanne, we are looking for
aSenior Scientist (Associate Principal), Analytical Development and
Quality Control Under the responsibility of the Head of Analytical
Development & Quality Control (AD&QC), the role brings a strong
technical expertise to the Pharmaceutical Development Department for
the analytical development and control of investigational medicinal
product (new chemical entities), manufactured by selected CDMOs.The
role is to define the analytical development strategy and lead the
analytical development activities on drug substances (DS) and drug
products (DP) with constant awareness of risks, efficiency and
quality. The candidate must have a thorough understanding of
pharmaceutical development. The expert participates in matrix-based
teams with a strong spirit of collaboration.Your responsibilities will
be but not limited to:Lead control strategies for DS and DP, taking
into consideration the status of the project, assessing risks, and
ensuring their mitigation: define specification and justification
thereof, lead the analytical method development and validation
programs, define the stability study strategies (development and ICH
studies) and evaluate the data in order to determine a shelf life,
lead the evaluation and characterization of impuritiesPreparation,
review, archiving of analytical CMC source documents for clinical
trial application (Quality section), acting as a support to CMC
Regulatory AffairsImplement the analytical strategies at CDMO’s/CRO’s,
act as the main point of contact, manage, challenge, lead activities
and assure the conformity (scientific and documentary) with external
partnersContribute to the development of the CMC strategy in a matrix
environment and provide key expertise to build a CMC plan with the
view to speed time to clinicSupport DS and DP formulation/process
development with high-throughput analytical proceduresParticipate to
the selection of relevant CDMOs/CROs by reviewing the proposed
analytical packagesConduct studies to increase the understanding of
the molecule and support the process development activities in
collaboration with the other CMC team members, with a view to
out-licensing and marketing authorization dossiersDrive continuous
improvement initiatives within the AD&QC unit and the Pharmaceutical
Development department, identifying opportunities to enhance
efficiency, reliability, and complianceRequirementsMaster degree or
PhD in analytical chemistry, pharmaceutical sciences, or a related
field Minimum 5-7 years industrial experience in a pharmaceutical
manufacturing organization at various stages of project development,
working in hands-on analytical development roles and within
multidisciplinary teams (API development, Drug product formulation/
manufacturing, Quality, Regulatory)Strong background and extensive
hands-on experience with development and validation of various
analytical methods including but not limited to chromatography
(LC,GC), spectroscopy and spectrometry (MS) techniques Peptide
characterization experienceGood knowledge of synthetic API
chemistryComprehensive understanding of the global development of new
chemical entities from preclinical to late-stage clinical development
Good understanding of the management of a network of CDMO’s and CRO’s
Strong understanding of regulatory/quality requirements (GMP,
Pharmacopeias, ICH, FDA guidance…) applicable to investigational
medicinal productsScientific curiosity, flexibility, detail-oriented
and capable of identifying and solving complex scientific
problemsExcellent communication and demonstrated strong interpersonal
skills, ability to work in a CMC team environment with cross
functional interactionsAbility to deliver complex objectives under
challenging timelines in a rapidly changing environment. Strong
resilience skillsExcellent knowledge of English Motivated to undertake
a diverse role and add value to the organizationBenefitsDebiopharm
offers employees:International, highly dynamic environment with a
long-term vision.Cross-functional collaboration at the forefront of
the most advanced scientific developments in oncology and
anti-bacterial industry.Exposure to a wide variety of areas and
functions within clinical development and the pharmaceutical
industry.Participation in a company where innovation, people and
entrepreneurship are the fundamental keys to success.Proud to be an
Equal-Pay certified, we ensure offering to all our employees the same
opportunities. The use of external staffing agencies or recruiters
requires prior approval from our Human Resources Department. The Human
Resources Department at Debiopharm requests external staffing agencies
or recruiters not to contact Debiopharm employees or members of the
Board of Directors directly in an attempt to present
candidates.Submission of unsolicited resumes in advance of an
agreement between the Human Resources Department and the external
staffing agency or recruiter does not create any implied obligation on
the part of Debiopharm.Debiopharm will not accept unsolicited resumes
from any source other than candidates themselves for either current or
future positions.Job SummaryID: 966F8A049CDepartment: Pharmaceutical
DevelopmentType: full time
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