Downstream Manufacturing Supervisor (Mon-Fri, 3rd
Company: Rentschler Biopharma Inc.
Location: Milford
Posted on: August 7, 2022
Job Description:
Job DescriptionJob SummaryRentschler Biopharma, headquartered in
Laupheim, Germany, is a leading contract development and
manufacturing organization (CDMO), focused exclusively on client
projects. Rentschler Biopharma offers process development and
manufacturing of bio pharmaceuticals as well as related consulting
activities, including project management and regulatory support.
Rentschler expanded its global footprint by opening a facility in
the Boston metro area in Milford, MA. This site answers our US
clients' strong request to bring our expertise, innovation and
state of the art, high-quality development, and manufacturing
across the Atlantic to better serve the unique US market, a key
market for Rentschler Biopharma. Milford's proximity to our key US
clients and Boston metro's many biotech startups, large
pharmaceutical companies, incubator sites, world-class universities
and biotech-focused research institutions enable us to strengthen
our important US partnerships and forge new ones, elevate our
technological capabilities and tap into the region's wide pool of
expert talent.We are recruiting for a proactive, strategic, and
"hands-on" Supervisor, Manufacturing – Downstream. This position is
responsible for overseeing daily activities on the designated shift
for Downstream operations (purification, formulation, etc.) at the
Milford MA biomanufacturing facility. In addition to overseeing the
daily activities of the associates on the shift, the hands-on
Supervisor will work alongside the associates executing
manufacturing operations and batch records. This position will
assure that the entire team is in strict compliance with current
Good Manufacturing Practices (cGMP), environmental health and
safety guidelines and any other regulations that may
apply.Downstream Manufacturing Supervisor (Mon-Fri, 3rd Shift)
(23:30-8:00)Key Experience/ Responsibilities for Shift Supervisor -
Downstream
- Hands-on supervision of manufacturing staff including hiring,
coaching, training, goal setting, professional development, overall
performance management and assessment.
- Maintain personal training requirements and assure that each
team member is adequately trained and documented for the execution
of production SOP's and MPR's.
- Subject Matter Expert in cGMP downstream manufacturing;
especially with Chromatography, Column Packing, Tangential Flow
Filtration (TFF), Ultrafiltration/Dia-filtration (UF/DF),
Nanofiltration, Formulation, Bulk Drug Substance Aliquoting.
- A thorough understanding of purification key performance
indicators, column volumes, retention time, resin loading, linear
velocity, TFF membrane loading, dia-filtration factor, LMM and the
science behind the downstream production of mAb's.
- Specific equipment/systems that we are using include Cytiva
Single Use Mixers (100L, 200L, 500L, 1000L), Cytiva AKTA Ready
chromatography skid, Cytiva AKTA Ready Flux XL TFF, TCU's, BSC's,
Millipore and Sartocheck integrity testers, and disposable
technology systems. Must have a thorough understanding of the
equipment and controls as this role will be the front-line
troubleshooting and correction role for the shift.
- Author, revise and approve SOP's, batch records, deviations and
other documentation as required to ensure compliance.
- Thoroughly familiar with the identification of actions and
results that are outside procedures and limits which require
escalation through events and deviations. Responsibilities include
leading and completing investigations of root causes and formally
documenting/writing deviations for such events in downstream.
- Subject matter expert for materials and the ordering of
materials in time to meet the schedule. Participates in inventory
cycle counts and resolution/ corrective actions for
discrepancies.
- Assures that SAP transactions for process orders are executed
on time and works with supply chain to resolve any
discrepancies.
- Schedules daily activities for the shift, tracks completion of
activities and reports on progress to downstream manufacturing
manager.
- Insure that executed batch records are reviewed thoroughly and
all entries are correct before turning over to QA for approval.
Works to resolve batch record entry issues before they are reviewed
by QA.
- Leads or oversees new employees training (as executed on the
floor) to understand what new employees are trained to perform and
can document in batch record, prevents task execution before
training is documented.
- Warrant activities in the suite are conducted safely and in
accordance with Safety procedures.Ways of Working – Leadership
CapabilitiesThe Manufacturing Supervisor is in the suite as a
working manager of the team members on the shift that reports to
them. The function of the job requires coordination of the team,
responsibility for achieving team objectives, personnel training,
capabilities and team morale. Additionally, this role is highly
involved in communicating and coordinating with support
organizations and leadership. The following leadership capabilities
are required for this role.Characteristics: adaptable to changes,
works well on the floor alongside of manufacturing associates,
cross functionally and with key stakeholders. Self-motivated, takes
initiative and drives for solutions with the team.Collaborates with
and provides open, honest, technically accurate information to
support teams (Eng., Fac, PS, QA, QC, SC) during scheduling
meetings, event/deviation investigations and process/ equipment
troubleshooting.This position responsible for assuring training of
new employees and for developing new competencies in existing/
transferred personnel. This can be done personally or by scheduling
of the site's qualified trainers (QT). Must be experienced with
training models and focused on building competencies and behaviors
to elevate the performance of team members.
- Monitors team culture provides clarity to misinformation and
legacy attitudes and behaviors.
- Elevates issues early, presents issues with options for quick
and compliant resolution.
- Provides feedback and SME support for training department
process improvements.
- Provides feedback to employee's performance on the shift.
- Leads team meetings and may facilitate multi-department
discussions.
- Supports a positive work environment that promotes inclusion
and diversityStandard Manufacturing Duties and ResponsibilitiesThe
Key Experience and Ways of working distinguish the Shift Supervisor
from the Manufacturing Associate roles. However, the Shift
Supervisor is on the floor, operating the equipment and completing
batch records alongside the manufacturing associates. The following
manufacturing responsibilities are also performed:
- Perform operations of the following (may be applicable to
commercial scale product, development studies, clinical scale, or
validation activities).
- Perform, Monitor, Review, and record batch parameters,
including computer data entry. Complete relevant paperwork
following GDP/GMP guidelines. Perform mathematical calculations
related to production processes.
- Pushing buffer containers ranging from 50L to 200L.
- Sitting for periods of 2 to 3 hours.
- Knowledge of laboratory and pharmaceutical production equipment
including but not limited to autoclaves, process tanks,
chromatography skids and columns, analytical equipment.
- Lead Continuous Improvement Teams (such as 5S, Gemba, OMT,
etc.).
- Such additional responsibilities as the Company may also
assign.
- Proficient in BSC operations and aseptic
technique.Qualifications
- High school diploma & 5+ years of experience
- Associate degree in Life Sciences/Engineering field & 3+ years
of experience
- Bachelor's degree & 4+ years of experience
- 2+ years' experience as a Lead operator, supervisor or manager
in Life Sciences.Working Conditions
- Normal office working conditions: computer, phone, files, fax,
copier.
- Personal Protective Equipment must be worn as required.
- May require lifting amounts of 25 lbs.
- Manufacturing operations tasks requires operator to regularly
remain on feet for shift.
- PPE as required
Keywords: Rentschler Biopharma Inc., Worcester , Downstream Manufacturing Supervisor (Mon-Fri, 3rd, Other , Milford, Massachusetts
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