POSTDOCTORAL SCIENTIST

JOB SUMMARY:

We require a highly motivated Postdoctoral Scientist to work on

protein stability & aggregation as it relates to therapeutic protein development. The

current postdoctoral project is designed to understand the fundamental mechanism/s of

protein instability, sub-visible particulate formation and aggregation using variety of

chromatographic, biophysical and biochemical tools.

DUTIES AND RESPONSIBILITIES:

SCIENTIFIC RESPONSIBILITIES:

•

Evaluate physical and biophysical properties of peptides and proteins relevant to

drug development and subsequently communicate the interpretation and

implication of results to clients.

•

Develop analytical and high throughput biophysical methods to characterize

product variants

•

Execute and oversee specialized analytical testing and generation of technical

documents

•

Maintain a strong awareness of current scientific literature, particularly in the area

of protein characterization, and actively apply new concepts as appropriate.

•

Develop and evaluate new cutting-edge technologies for protein product

understanding, especially product heterogeneity and impact on safety and

efficacy.

•

Design experiments to develop pre-clinical and clinical formulations of drug

candidates to support drug discovery and development.

•

Design experiments to determine the stability in prototype clinical formulations,

to detect and identify the decomposition products, and to achieve formulations

with acceptable shelf-life.

•

Perform laboratory experiments related to the above.

•

Create presentations for outside scientific meetings and conferences to showcase

Wolfe Laboratories’ scientific leadership in the field of protein analysis and

characterization.

CLIENT INTERACTION RESPONSIBILITIES:

•

Interface with clients to develop an in-depth understanding of client objectives

and define solutions to meet their program requirements

•

Develop compelling approaches and solutions to address client needs

•

Write persuasive proposals for the projects

•

Regularly interact with clients to keep them abreast of project progress

•

Write and review interim and final reports.

REQUIRED BACKGROUND AND EXPERIENCE:

•

Ph.D. in Biochemistry, Biophysics, Chemistry, Biomolecular engineering,

Chemical engineering or closely related disciplines

•

In depth experience in the area of protein biophysics involving structure-foldingstability

relationships. This includes purification, stability, kinetics and

thermodynamics of folding of monomeric proteins, particularly as they relate to

the pre-formulation and formulation development of new drugs

•

Hands-on experience with chromatographic method development as well as

techniques used for biophysical characterization of biopharmaceutical products

such as calorimetry, spectroscopy, higher order structure analysis, protein mass

spectroscopy, CE, HPLC, ELISA, and carbohydrate analysis.

•

A demonstrated drive to apply technical knowledge to developing drug

formulations

•

Established track record of significant contributions as an individual technical

expert

•

Outstanding written and oral communication skills as well as polished and

persuasive client presentation skills

ADDITIONAL DESIRABLE BACKGROUND:

•

Post doctoral experience in analytical biochemistry or closely related discipline.

•

Good understanding of excipient and ligand interaction with proteins

•

Evaluation of thermodynamic and kinetic models

WHERE THIS JOB COULD LEAD:

At Wolfe Laboratories Inc., we pride ourselves on retaining and growing our team

members, and ensuring they are developing to their full potential. This position can

provide many different avenues for advancement, including:

•

Training towards becoming a Project Manager

•

Leader of an innovative business line

•

Become a Lead Technical Researcher

•

Managing a team of Postdoctoral employees

Interested candidates are requested to email a copy of their resume with a cover letter

including salary history to:

This email address is being protected from spambots. You need JavaScript enabled to view it.

Wolfe Laboratories, Inc. (WLI), located in Watertown, MA, is a premier contract research

organization that provides integrated early drug development solutions to the biopharmaceutical

industry. Wolfe Laboratories is an essential element of the drug development ecosystem,

recognized by global and virtual biopharmaceutical companies as a science-driven organization

whose mission is to provide outstanding discovery and development services tailored to its

clients’ needs for rational formulation development. Wolfe Laboratories integrates the critical

path components of early development to ensure that programs advance while meeting rigorous

scientific demands with flexibility to address dynamic challenges and aggressive timelines.

Wolfe Laboratories’ vision is to improve human health, and we continue to strive towards that

goal by embracing our core values of integrity, excellence and teamwork. The company has a

high percentage of repeat clients, which is a testament to its long-term commitment of continual

investment in its capabilities to meet biopharma’s growing demand for high quality, integrated

early development services.

For more information visit us at:

www.wolfelabs.com

.

Wolfe Laboratories, Inc is an Equal Employment Opportunity employer.

Merck-Wolfe Laboratories Postdoctoral Fellowship

Biopharmaceutics/Solid Form Definition

JOB SUMMARY:

Merck Research Laboratories and Wolfe Laboratories have created a unique postdoctoral

fellowship program. In this highly competitive and challenging program, the

postdoctoral fellow is expected to conduct basic biopharmaceutics research as well as

perform applied R&D. For the basic research project, the successful candidate will be

mentored by Merck scientists on research that is expected to generate peer-reviewed

publications. For the applied R&D projects, the successful candidate will work with the

Wolfe scientific team to advance our clients’ programs from discovery into early clinical

development. The postdoctoral fellow will work at Wolfe Laboratories’ Watertown, MA

facility.

 

An understanding of the phenomena governing intestinal absorption of drugs following

oral administration is a topic of great interest to both academia and industry. The

successful candidate will utilize physical chemistry, pharmaceutics and solid-state

chemistry, with a goal of better understanding the mechanistic underpinnings of variable

drug absorption as a function of physicochemical properties. Wolfe Laboratories seeks a

PhD scientist who will be responsible for the advancement of structure-based approaches

to effectively design solid forms for optimal drug product performance, the identification

of pharmaceutically-relevant forms through comprehensive polymorph/solvate

crystallization screening, and the assessment of relevant physicochemical properties in

support of form selection. Several known or hypothesized formulation and release

mechanisms will be interrogated, including amorphous solid dispersion supersaturation,

precipitation of drug from formulation vehicles or gastric media (i.e., weak bases), and

drug release kinetics from hydrophilic (e.g., polyethylene glycol) and lipid (e.g., mono-,

di-, and triglyceride) systems. The scientist must have a thorough knowledge of the

thermodynamics of drug crystal forms needed to elucidate their phase relationships, a

broad understanding of the application of designer solid forms and super saturation

strategies for solubilization, and of crystal nucleation and growth kinetics needed to

optimize solid form evaluations. The ultimate goal shall be to predict relative

pharmacokinetic performance and variability in animals using calculated and measured

properties of drug compounds and their formulations.

Collaboration is at the core of our success. The successful applicant will be a key member

of the team and will be responsible for understanding dissolution and absorption

characteristics of drug forms and formulations. The candidate will utilize a wide range of

in vitro

 

, in situ, and in vivo

techniques to achieve this goal. Creativity and innovation,

built on sound technical knowledge and excellent problem-solving skills, are required in

order to meet the challenges posed by today’s new chemical entities.

 

DUTIES AND RESPONSIBILITIES:

SCIENTIFIC RESPONSIBILITIES:

•

Identify and leverage state-of-the-art technologies to design crystal forms (crystal

engineering) and crystallization processes (particle engineering)

•

Lead, design and/or conduct crystallization screens for drug crystal forms,

including salts, cocrystals, polymorphs and solvates

•

Leverage a variety of physical-chemical characterization techniques to identify

novel crystal forms and to assess relevant physical properties in support of crystal

form selections for drug products

•

Design strategies and implement best business practices for comprehensive solid

form (salt, polymorph) screening and selection

•

Develop a thorough understanding of the CM&C development strategy with

respect to physicochemical properties and formulation development

•

Provide effective technical leadership to integrated drug substance and drug

product development teams

•

Ensure understanding and adherence to applicable laboratory quality systems.

•

Adopt good documentation practices by properly documenting experiments and

writing high quality technical reports

•

Provide mentoring and develop the technical breadth/depth of associate-level

scientists responsible for crystallization screening and formulation development

•

Serve as a corporate technical resource in the chemistry of pharmaceutical solids

(polymorphism, crystallization, X-ray diffraction, thermal analysis, moisture

sorption analysis, solubility, microscopy, etc.)

•

Perform laboratory experiments related to the above.

•

Create publications and presentations for outside scientific meetings and

conferences to showcase Wolfe Laboratories’ scientific leadership in the field of

small molecule analysis, characterization and formulation development.

CLIENT INTERACTION RESPONSIBILITIES:

•

Interface with clients to develop an in-depth understanding of client objectives

and define solutions to meet their program requirements

•

Develop compelling approaches and solutions to address client needs

•

Write persuasive proposals for the projects

•

Regularly interact with clients to keep them abreast of project progress

 

REQUIRED BACKGROUND AND EXPERIENCE:

Write and review interim and final reports.

•

PhD in Organic, Physical or Analytical Chemistry, Pharmaceutical Chemistry,

Chemical Engineering, or a related field

•

Up to 5 years of relevant experience in academic or pharmaceutical solid state

chemistry

•

Deep technical knowledge/expertise in organic solid-state chemistry

(crystallization, thermodynamics, solid-state characterization) and/or

pharmaceutical sciences

•

Relevant experience in crystallization, physical characterization techniques (i.e.,

thermal and moisture sorption analyses, microscopy, chromatography, solubility,

powder and single crystal X-ray crystallography, solid-state NMR spectroscopy)

and dissolution and/or crystal modeling

•

Outstanding written and oral communication skills as well as polished and

persuasive client presentation skills

 

ADDITIONAL DESIRABLE BACKGROUND:

•

Expertise in computational solid-state chemistry (crystal structure prediction,

structure solution from XRPD data, structure-property prediction, molecular

dynamics simulations, SSNMR chemical shift prediction)

Interested candidates are requested to email a copy of their resume with a cover letter

including salary history to:

This email address is being protected from spambots. You need JavaScript enabled to view it.

Wolfe Laboratories, Inc. (WLI), located in Watertown, MA, is a premier contract

research organization that provides integrated early drug development solutions to the

biopharmaceutical industry. Wolfe Laboratories is an essential element of the drug

development ecosystem, recognized by global and virtual biopharmaceutical companies

as a science-driven organization whose mission is to provide outstanding discovery and

development services tailored to its clients’ needs for rational formulation development.

Wolfe Laboratories integrates the critical path components of early development to

ensure that programs advance while meeting rigorous scientific demands with flexibility

to address dynamic challenges and aggressive timelines. Wolfe Laboratories’ vision is to

improve human health, and we continue to strive towards that goal by embracing our core

values of integrity, excellence and teamwork. The company has a high percentage of

repeat clients, which is a testament to its long-term commitment of continual investment

in its capabilities to meet biopharma’s growing demand for high quality, integrated early

development services.

 

We have a steady 14-year track record of growth, success and profitability.

For more information visit us at:

www.wolfelabs.com.

Wolfe Laboratories, Inc is an Equal Employment Opportunity employer.