Standortleiter (m/w/d) (Biowissenschaftler/in)

Site Head Commercial Manufacturing Individualized Cancer Vaccines (m/f/d)
Mainz, Germany | full time | Job ID: 8563

We are seeking a highly motivated and experienced Site Head (m/f/d) for our commercial manufacturing site for individualized cancer vaccines. The position is responsible for managing strategic alignment with platform targets, business execution on timelines, capacities and budget. Leadership of all local departments (manufacturing, site engineering, quality control) and alignment with the network. The Site Head will also be responsible for ensuring compliance with all regulatory requirements and for maintaining a safe and efficient work environment.
Lead and manage the Clinical production team, including production, site engineering, and quality control personnel
Develop and implement production plans to ensure timely delivery of clinical trial and commercial products
Ensure compliance with all regulatory requirements, including cGMP, FDA, and EMA regulations
Oversee the development and optimization of production processes to improve efficiency and strongly reduce costs
Collaborate with cross-functional teams to ensure alignment of production activities with commercial objectives and collaboration partners
Manage relationships with external vendors and partners to ensure timely delivery of materials and services
Ensure a safe and efficient work environment, including compliance with all safety regulations and procedures
Develop and manage the site budget, including capital expenditures and operating expenses
Develop and implement strategies to optimize production capacity and improve profitability

Master`s degree in a scientific or engineering discipline
Minimum of 10 years of experience in commercial manufacturing operations, including at least 5 years in a leadership role
Extensive knowledge of cGMP, FDA, and EMA regulations, experience with individual products preferred
Strong leadership and management skills, with a demonstrated ability to lead cross-functional teams
Excellent communication and interpersonal skills, with the ability to build strong relationships with internal and external stakeholders
Strong problem-solving and decision-making skills, with the ability to think strategically and tactically
Experience managing budgets and financial performance

If you are a strategic thinker with a passion for innovation and a proven track record of success in shaping the organization and deliver on targets, we encourage you to apply for this exciting opportunity. It's our priority to support you:

Your flexibility: flexible hours | vacation account
Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
Your health and lifestyle: Company bike
Your mobility: Job ticket | Deutschlandticket
Your life phases: Employer-funded pension | Childcare

Site Head Clinical Manufacturing Individualized Cancer Vaccines (m/f/d)
Mainz, Germany | full time | Job ID: 8562

We are seeking a highly motivated and experienced Site Head (m/f/d) for our clinical manufacturing site for individualized cancer vaccines. The position is responsible for managing strategic alignment with platform targets, business execution on timelines, capacities and budget. Leadership of all local departments (manufacturing, site engineering, quality control) and alignment with R&D and the future commercial site. The Site Head will also be responsible for ensuring compliance with all regulatory requirements and for maintaining a safe and efficient work environment.
Lead and manage the Clinical production team, including production, site engineering, and quality control personnel
Develop and implement production plans to ensure timely delivery of clinical trial materials
Ensure compliance with all regulatory requirements, including cGMP, FDA, and EMA regulations
Oversee the development and optimization of production processes to improve efficiency and reduce costs
Collaborate with cross-functional teams to ensure alignment of production activities with clinical development plans and collaboration partners
Manage relationships with external vendors and partners to ensure timely delivery of materials and services
Ensure a safe and efficient work environment, including compliance with all safety regulations and procedures
Develop and manage the site budget, including capital expenditures and operating expenses

Master`s degree in a scientific or engineering discipline
Minimum of 10 years of experience in clinical manufacturing operations, including at least 5 years in a leadership role
Extensive knowledge of cGMP, FDA, and EMA regulations, ATMP experience preferred
Strong leadership and management skills, with a demonstrated ability to lead cross-functional teams
Excellent communication and interpersonal skills, with the ability to build strong relationships with internal and external stakeholders
Strong problem-solving and decision-making skills, with the ability to think strategically and tactically
Experience managing budgets and financial performance
At BioNTech, we are more than just a biotechnology company - we are a community of innovators, scientists, and leaders dedicated to
revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide,
especially by addressing diseases with high medical needs like cancer and various infectious diseases.

Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop
business strategies driven by our shared passion for advancing medicine.

Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and
become part of a mission that has the potential to change lives around the world.

BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality,
ethnic or social origin, age, romantic orientation, marital status, disability, physical appearance, health status or any other aspect of personal status.
We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important - it’s a match!

Stellendetails

- Location: Mainz-Bingen area
- Availability: immediately
- Option to take over: yes
- Type of contract: unlimited
- Type of employment: Temporary employment
- Working hours: Full-time (37.5 hours/week)
- Remuneration: 5,153 euros gross/month plus variable, performance-related bonus

Who we are looking for

We are looking for a full-time Artwork Launch & Change Implementation Coordinator (m/f/d) for our client, an internationally operating industrial company .

What you bring along

- Bachelors degree with major focus on life sciences and/or economics
- min. 3 years of relevant experience in Supply Chain Management or Change Management projects
- good knowledge of artwork process
- solid Know-How of Supply Chain regulations and their application
- good knowledge of launch/Change process
- dedicated team player with excellent communication skills and independent working style
- fluent in English read/write/speak, some fluency in German is preferable

The Job

- Ensure compliance to country regulatory requirements.
- Contribute to the implementation and the maintenance of the Quality Management System and ensure continuous improvement thereof.
- Notify potential quality/compliance gaps/ riks to Global Process Compliance.
- Support the preparation of internal and external inspection/ GxP audits.
- Contribute to the review of procedures for the organization as well as for the processes against external and internal GxP requirements.
- Report non compliance events with respects to the procedures assigned and any discrepancies with potential quality impact.
- Perform, understand and document training as assigned.

Benefits

- long-term employment with a renowned client company with good chances of being taken on
- good accessibility to the client company, also by public transport
- personal and cooperative support from our branch office
- advice on other vacancies and career opportunities if desired
- up to 30 days vacation
- flexible working time account options
- uncomplicated transfer of your monthly working hours
- referral bonus - employees recruit employees (150 euros per successful referral)
- exclusive employee discounts at many retailers (e.g. Zalando, IKEA, HelloFresh! - changing providers)

Further

- employment initially limited for 6 months (option for takeover or extension is given)
- proportionate mobile working is possible

Kontaktinformationen

Frau Sarah Jung
Office Events P & B GmbH
Freseniusstraße 29
65193 Wiesbaden

Telefon: +49 611-97164580
E-Mail: [email protected]

Stellendetails

- Ort: Landkreis Mainz-Bingen
- Verfügbarkeit: ab sofort
- Option auf Übernahme: ja
- Vertragsart: unbefristet
- Beschäftigungsart: Arbeitnehmerüberlassung
- Arbeitszeit: Vollzeit (37,5 Std./Woche)
- Vergütung: 4.468 EUR brutto p. M. zzgl. variabler, leistungsorientierter Prämie

Für wen suchen wir

Wir suchen für unseren Kunden, einem international agierenden Industrieunternehmen im Raum Mainz-Bingen, einen Operational Specialist (m/w/d) in Vollzeit.

Das bringen Sie mit

- Bachelor's degree (business administration, life sciences or similar preferred) or equivalent education/experience, Master's degree or PhD is a plus
- independent working and dilligence
- Enjoy working with numbers and quantitative analysis
- Strong communicator, positive mindset, agile and flexible
- professional communication and behavior towards team members and senior managers
- fluent written and spoken English
- MS-Office, advanced knowledge of Excel and SharePoint, working in and with large data bases and numbers

Der Job

- Responsible/in charge to support consultation efforts in BDS (Biostatistik & Data Sciences) Operations through collection and preparation of relevant information needed for analysis
- Prepares and sends communications relating to Strategic Country Lists and Country Allocation to Business Regions. Maintains distribution lists for such communications
- Monitor the Feasibility Mailbox and manages queries from the Business Regions & Trial teams
- Sets up Country Feasibility trainings and liaises with trial teams for training materials (responsible for Q&A, video recordings and subsequent filing of documentation)
- Manages activities associated with country outreaches (communication, follow-up on deadlines, collation of results etc.)
- Creates and maintains folder structures in MS Teams for country outreach and country allocation
- Reviews & analyzes Focus and CTMS Reports regarding baselines/plan dates and supports maintenance of timelines in the various systems
- Reviews and prepares tables from various benchmark databases in order to support the team members in the assessment of program and trial benchmarks
- Conducts administrational support such as the preparation, consolidation and documentation of Excel and Power Point analysis
- Establish Gantt Charts
- Support of preparation of Benchmark Analysis, Checking Data, creating Tables. construct queries and store results, summarize and link to results
- Maintain agenda and minutes for team meeting or Radar meeting, act as timekeeper in the meetings

Vorteile

- langfristiger Einsatz bei einem renommierten Kundenunternehmen mit guten Übernahmechancen
- gute Erreichbarkeit des Kundenbetriebs, auch mit den öffentlichen Verkehrsmitteln
- persönliche und partnerschaftliche Betreuung durch unsere Niederlassung
- Beratung auch zu anderen Vakanzen und Karrieremöglichkeiten falls gewünscht
- bis zu 30 Tage Urlaub
- flexible Gestaltungsmöglichkeiten bezüglich des Zeitkontos
- unkomplizierte Übermittlung Ihrer monatlichen Arbeitszeit
- Empfehlungsprämie – Mitarbeiter werben Mitarbeiter (150 Euro pro erfolgreiche Empfehlung)
- exklusive Mitarbeiterrabatte bei vielen Händlern (z.B. bei Zalando, IKEA, HelloFresh! – wechselnde Anbieter)
- kostenfreie Parkplätze

Sonstiges

- 40% Homeoffice möglich
- Einsatz vorerst befristet für 2 Jahre mit Option auf Verlängerung und Übernahme

Kontaktinformationen

Frau Sarah Jung
Office Events P & B GmbH
Freseniusstraße 29
65193 Wiesbaden

Telefon: +49 611-97164580
Fax: +49 611 9716458-8
E-Mail: [email protected]