About the role
This is what you will do:
This
D evelopment Scientist I I
will be a key team member in Alexion’s
External
A nalytical
Development and Quality Control group.
This position
- is
- responsible for
- maintaining
- the highest standard of quality and compliance
- of
- external
- quality control
- testing
- (GMP) laboratories.
This candidate will
- be responsible for
- initiation and ownership of
- laboratory investigations (LIRs)
- through
- strong liaison
- with
- external contract laboratories
- and
- change controls relevant to ADQC biologic programs . The candidate will
- ensure
- timely , compliant, and high-quality delivery
- for LIR closure to
- enable the
- generation of final
- release
- CoAs . The role will
- work closely with
- internal Quality
Assurance
, Compliance, Analytical Development and
Stability
teams
to ensure product to patients.
You will
be responsible for :
Responsible for generating
- and/or mirroring , reviewing, providing
- assessments,
- and driving ownership of
LIRs to close out
- Out-of-Specification (OOS), Out-of-Trend (OOT), and atypical results
- with
- structured root cause analysis, impact
- assessment,
- and/or
- corrective/preventive actions (CAPA s ) .
- D esign
- investigational
- testing
- plan s ensuring compliant closure of all testing related investigations within the quality system.
Lead
- and/or
- facilitate
- cross-functional meetings with quality assurance to ensure structured investigation alignment.
Create plans
- ,
- track,
- and present timelines to meet established targets,
- goals,
- and
- objectives .
- Perform review of analytical data to ensure expected assay performance.
Identify
opportunities for improvement in systems and make recommendations for effective changes to ensure compliance with
cGMP .
Strong presentation skills
You will need to have:
- A successful candidate will have
- strong
- m ental a cuity
- with h igh attention to detail and ability to maintain accuracy in documentation and processes.
- Excellent analytical and problem-solving skills with the ability to conduct risk assessments and root cause analysis.
- A broad knowledge of Pharmaceutical Quality Assurance,
- regulatory compliance, and/or quality control inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
Strong proficiency in quality management systems and effective communication skills for interacting with cross-functional teams
.
Strong
- proficiency
- with MS
- W ord,
- E xcel,
PowerPoint
- .
- Ability to bend, reach and stand , with
- lifting to 15 pounds and
- carrying
- over short distances .
- Ability to travel up to 10%, if needed.
- Advanced (M.S. or Ph.D.) degree in Biochemistry, Chemistry or related discipline with
- 2 - 5
- years (Ph.D.) or
- 10 + (M.S.) hands on biological analytical development experience in
- pharmaceutical
- industry.
We would
prefer
you to have:
Working knowledge in validated documentation systems: Veeva Vault (EQV), LIMS,
ValGenesis
,
Kneat
- , etc.
- Knowledge of pharmaceutical/biotechnology manufacturing process
- D atabase management /statistical analysis (e.g., JMP, Tableau, SAS)
- with
- proficiency
- in Microsoft
SharePoint
and/or BOX .
Date Posted 07-Oct-2026 Closing Date 29-Oct-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.