heike abeck

senior director, manufacturing sciences and technology analytical methods

About

I am direct, authentic as well as flexible. I am able to integrate technical knowledge to lead Teams and people in a goal oriented manner to practical solutions in line with the organization’s objectives. * Successful track record in implementing improvement projects, project portfolios, CMC and capital projects * Broad experience in managing and working with international teams in various countries * Extensive technology transfer experience of biologics and monoclonal antibodies * Preclinical and Phase I-IV product development experience * Thorough knowledge of leading, organizing and working in cross- functional teams * Fluent in English and German, conversant in Spanish

Country

united states

City

albany

Industry

biotechnology

Skill

technology transfer, biotechnology, cross functional team leadership, manufacturing, validation, product development, fda, gmp, pharmaceutical industry, biopharmaceuticals, process engineering, process simulation, 21 cfr part 11, change control, capa, v&v, process optimization, project management, sop, quality system, clinical development, quality control, computer system validation, project planning, quality assurance, gxp, regulatory submissions, chromatography, capital projects, due diligence, portfolio management, biosimilars, standard operating procedure, corrective and preventive action

Experience

director validation management, manufacturing sciences and technology

bayer

2017-7 - Present · 9 yrs 3 mos

Led a cross-functional Team through process and cleaning Validation activities for Antihemophilic recombinant Factor VIII (Kovaltry) at 2nd production site. Aligned production sites on production process and clarify comparability plans.

production director

bayer healthcare

2018-11 - Present · 7 yrs 11 mos

* Lead the rampdown team to design and execute plans for process, utility, systems, raw materials and building shutdown. * Led the production teams in timely execution of Development runs, GMP readiness and validation runs for buffer preparation, fermentation and purification area. * Provided analytical and process details/ insights for product comparability decisions at top management level.

senior director, manufacturing sciences and technology analytical methods

bayer healthcare

2019-9 - Present · 7 yrs 1 mo

Build up and lead the global Analytical MSAT Team to support commercial and pipeline products

director, manufacturing sciences and technology

novartis

2013-11 - 2015-5 · 1 yr 7 mos

Led the MSAT team including lab managers, lab associates and process experts. Initiated and successfully completed restructuring of the group. Managed ongoing production support DRs/CAPAs, Product impact assessments along with improvement project work as needed for the business.

senior technical project leader

sandoz

2008-1 - 2010-11 · 2 yrs 11 mos

Worked as CMC Lead for 2 key biosimilar products and technical lead for several Novartis monoclonal antibodies. Provided clinical material for 1st Novartis Biosimilar to start clinical studies on time. Established process for biosimilar product development allowing future biosimilars faster development timelines by possibly 6-12 months.

senior and principal process engineer

chiron corporation

2001-1 - 2005-1 · 4 yrs 1 mo

Completed Capacity Analysis allowing manufacturing to realize 2x the throughput with minimal capital expenditures for several biologic products. Completed several Capital projects (1-50M) on time and below budget introducing new purification suites, new CIP skid, new purification controllers, new product and buffer tanks including equipment, cleaning and process validation.

manufacturing specialist

chiron corporation

2000-1 - 2001-1 · 1 yr 1 mo

Optimized equipment and facilities to allow ~20% faster production throughput by improving task sequencing and transfer line concepts.

process and design engineer

bechtel corporation

1997-1 - 2000-1 · 3 yrs 1 mo

Completed conceptual and detailed design converting single use BioTech facility to multi use facility on time. Aided in international Russian/American treaty by designing rocket motor incineration facility in Russia.

environmental engineer

bechtel corporation

1996-1 - 1997-1 · 1 yr 1 mo

Successfully closed military base by devising soil, water and air clean up plan.

air quality specialist

aecom

1995-1 - 1996-1 · 1 yr 1 mo

Designed 1st available pollution model for coal dust particulates.

researcher

the dow chemical company

1994-5 - 1994-9 · 5 mos

Independently devised procedures and tools to test the strength of plastics. Operated Instron and other instruments to test Tensile Strength of plastics.

associate director, project and portfolio management and senior project manager

novartis

2010-4 - 2013-10 · 3 yrs 7 mos

Closed out 10+ remediation projects on time, including compliance, quality and improvement projects and FDA commitments allowing the company to avoid future FDA observations. Managed the project portfolio by facilitating monthly project review boards focusing on the projects in need. Established a tracker for division's projects including status. Established Project Management processes and templates allowing Project Managers in all functions to more efficiently execute their work

senior project manager

novartis

2005-1 - 2007-12 · 3 yrs

* Completed TechTransfer and regulatory submission for alternate production site, solving site capacity issues. * Established a production platform for antibodies which could allow for 1-2 year time savings in manufacturing readiness. * Provided project management for development of 2 monoclonal antibodies in Phase I/II.