Upstream Manufacturing Supervisor

2 weeks ago

Milford, Massachusetts, United States Rentschler Biopharma Inc. Full time


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Upstream Manufacturing Supervisor (Sun-Wed) page is loaded

Upstream Manufacturing Supervisor (Sun-Wed)

Bewerben

locations

Milford, MA, United States

time type

Vollzeit

posted on

Vor 2 Tagen ausgeschrieben

job requisition id

JR1617

Rentschler Biopharma ist ein fhrendes

Auftragsentwicklungs-

und

Produktionsunternehmen

(CDMO) fr Biopharmazeutika. Am Hauptsitz in Laupheim, Deutschland, sowie einem zweiten Standort in Milford, MA, USA, bieten wir Full-Service Lsungen fr die

Bioprozessentwicklung

und die Herstellung hochwertiger Biopharmazeutika sowie damit verbundene Beratungsleistungen einschlielich Projektplanung und regulatorischer Untersttzung an. In Stevenage, UK, haben wir das auf Zell- und Gentherapie spezialisierte Unternehmen Rentschler ATMP Ltd. gegrndet.
Wir sind ein Familienunternehmen mit rund 1.400 Mitarbeiter/-innen aus 25 Nationen. Was uns bei Rentschler Biopharma vereint, ist die Leidenschaft fr das, was wir tun. Wir versetzen unsere Partner in die Lage, Patienten mit schweren oder seltenen Erkrankungen zu helfen.
Mit unserer Hingabe und unserem Wissen wandeln wir medizinische Forschung in ausgezeichnete Biopharmazeutika um. So leisten wir einen entscheidenden Beitrag zur weltweiten Verfgbarkeit essenzieller Therapien. Um unser langfristiges und nachhaltiges Wachstum zu sichern, bauen wir unser Team weiter aus. Werden Sie Teil unseres einzigartigen Teams und gestalten Sie mit uns gemeinsam die Zukunft der Biopharma-Branche

Key Experience/ Responsibilities:
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 SOPs and MPRs
Subject Matter Expert in cGMP upstream manufacturing; especially with Mammalian Cell Culture, Roller Bottles, Rocker Bioreactors, Fed batch and Profusion Bioreactors, Cell Harvest Clarification, Viral Inactivation, Buffer and Media preparation, and equipment preparation
A thorough understanding of cell culture key performance indicators, cell counts, seeding densities, confluence, and the science behind the upstream production of mAbs
Specific equipment/systems that we are using include Cellmate roller bottle robot, 20L/50L wave bioreactor, Cytiva 200L & 500L single use bioreactor, TCUs, BSCs, roller racks, incubators 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 SOPs, batch records, deviations and other documentation as required to ensure compliance

In depth familiarities 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 Cell Culture
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 Cell Culture manufacturing manager

Ensure 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 Capabilities

The 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.

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 sites 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 employees performance on the shift
Leads team meetings and may facilitate multi-department discussions
Supports a positive work environment that promotes inclusion and diversity
Qualifications
With

high

school diploma:
Required 5+ years of

related

experience required or an associate degree in Life Sciences/Engineering field, Biotech Certificate preferred
Also 2+ years experience as a Lead operator, supervisor or manager in Life Sciences

With

Bachelors

degree:
Required 2-6

years

of

related

experience

Demonstrated proficiency in leading a team for 1+ years.

Able

to

read

and follow detailed

written

instructions

and

have

good verbal/written communication

skills
Must be

able

to

author

technical procedures and create forms.
Familiar

with

standard troubleshooting approaches (problem

statement,

root cause analysis, corrections, etc.)
Good

computer skills, knowledge of Microsoft

Word,

Excel
Good

interpersonal skills and be

able

to work

effectively

and

efficiently

in

a

team

environment
Ability to meet schedule required; this position

may

include shift,

weekend,

holiday work

and

overtime

at

times,

as

dictated

by

the 365-day

per

year

production schedule
Ability to work

in

a clean room

environment

and comply with

hygiene

standards and use of

special

garments.

Additionally,

personal protective equipment must

be

worn

due

to safety requirements
Proficient in BSC operations and aseptic technique
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
Physical Requirements
PPE as required
May require lifting amounts of 25 lbs
Manufacturing operations tasks requires operator to regularly remain on feet for shift

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