April 2014


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Donnie Pulliam <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Thu, 17 Apr 2014 00:02:52 -0400
text/plain (170 lines)
Greetings PSDG,

Biogen Idec, a leader in biotechnology and the world’s oldest independent
biotech, is pleased to announce that we are currently recruiting for two
full-time permanent positions which may be of keen interest to the members
of this group.  Below are the detailed job descriptions for review and they
are also posted on Biogen Idec’s career website @ *

If you are interested in pursuing either of these opportunities, please
apply via our on-line careers website and/or contact George Kafes (contact
information is below) and he will be happy to provide you with additional

Alternatively, If you are not interested at this time, but know of someone
who may be a good match, please feel free to share the contents of this
*George Kafes** | Biogen Idec, Inc. <>*
*Talent Acquisition - Pharmaceutical Operations & Technology*
[log in to unmask] | Office: +1-919.993.1695

Biogen Idec is currently in an exceptional period of growth and we are
poised for continued success!  Biogen Idec offers outstanding compensation
and benefits as well as exceptional career advancement potential.  Please
visit the website for more information:  *

Thank you in advance for your time and attention.

Donnie Pulliam


Job #1: *Sr Scientist/Principal Scientist, Global Specifications*
based in *Cambridge,
MA or RTP, NC (Raleigh-Durham area).  *Requisition ID #: *22177BR*

*Job Description*

Lead a centralized function within Biogen Idec to manage global
specifications for products in various stages of development from Phase I
to late stage compounds as well as life cycle management of specifications
for commercial products.  Responsibilities include, but not limited to,
developing a strategic vision and a harmonized process around managing
global specifications, leading team discussions around selecting
appropriate tests/methods to design data driven specifications and
representing Quality on cross-functional teams for specifications setting.
The individual will also lead a Sr. management forum to gain internal
alignment and approval of specifications, coordinate preparation of
relevant regulatory sections and ensure appropriate change control system
is implemented to manage global specifications.  This is a highly visible
position within the organization and requires a strong leader with an
ability to drive complex decision in a collaborative manner.  Additional
qualifications for the position are outlined below.


• Knowledge of regulations and current best practices for setting data
driven specifications
• Technical background in Analytical Methodologies and sound scientific
understanding of quality/stability principles as well as data analysis and
statistics for setting specifications
• Demonstrated leadership skills; previous experience of demonstrated
leadership abilities
• Excellent communication and presentation skills; Strong oral and written
communication skills; ability to communicate with management, peers and
subordinates, both intra- and cross-site, effectively
• Excellent organizational skills; ability to multi-task and coordinate
multiple activities in parallel
• Strong decision-making capabilities with the ability to evaluate issues
in a panoramic manner; ability understand and communicate
risks/ramifications arising from key decisions to all levels of management
• Significant knowledge and understanding of FDA/EMA and other global
regulations and cGMPs
• Experienced project and people manager with the ability to deliver
results from cross-functional teams


Ph.D. with at least 10 years of relevant experience


Job #2:  *Sr Associate, QC Stability* based in *RTP, NC (Raleigh-Durham
area).*  Requisition ID #: *22216BR*

*Job Description*

The Senior Associate QC Stability will provide technical expertise and
leadership for the stability program of commercial and clinical products,
ensure compliance and support of company Standards, Practices, and SOPs as
well as ICH and FDA guidelines, and support operational and technical
aspects of GMP stability studies for drug substance, drug product,
reference standard, and placebo.  This includes design of stability
protocols, expiry dating, providing stability sections for submissions,
justification of shelf life specifications, managing and implementing
changes in stability studies, and stability investigations.  Summary of Key
•Design and oversee stability protocols
•Assign drug substance, drug product, and reference standard expiry
•Trend and evaluate stability data proactively
•Guide Sample Control and QC Laboratories in proper storage of stability
•Guide testing labs (in-house and contract) in proper testing / reporting
of stability samples
•Alert Quality organization about potential issues and evaluate remedial
•Author and review stability reports for regulatory submissions
•Contribute to major/critical manufacturing and/or laboratory
investigations (deviations, OOS, cross-site and cross-functional)
•Participate on CMC teams and attend regular meetings


• Minimum of 5 years direct experience in stability/formulation of
biological and/or small molecule products in the Pharmaceutical industry,
with 8+ years industry experience
• Knowledge of analytical methods and strong ability to analyze data
• In-depth knowledge of GMPs and global quality systems
• Thorough applied understanding of LIMS functions and capabilities, MS
Excel, and MS Powerpoint and a thorough understanding of statistical
concepts applicable to conduct of stability programs
• Good understanding of statistical analysis and interpretation of data
• Critical skills include: strong organizational skills, strong problem
solving skills and ability to work within time constraints with attention
to detail
• Knowledge of FDA/EMA regulations
• Strong technical writing, and oral and written communication skills


Bachelor's Degree in Biology, Chemistry, Biochemistry, Chemical/Biochemical
Engineering, or related disciplines with equivalent experience.


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